Career Diaries by Elemed

Dr. Ann O'Connell, PhD, is a visionary leader and expert in Medtech and Manufacturing skills development. As Head of Funded Projects for Medtech and Engineering at Ibec, she oversees over 100 upskilling programs annually. Her extensive and strategic portfolio addresses critical areas such as Research & Development, Manufacturing & Digitalisation, Quality & Regulatory, Sustainability, and Management & Leadership.With a PhD from University College Dublin (2014) and over 17years of industry experience at Intel Corporation and Irish Manufacturing Research, Ann has deep technical foundations in technology, digitalisation, data science, and intelligent automation which informs her current work, where she applies her expertise to empower industries to address some of the world's most pressing challenges in health and environmental sustainability. Ann's commitment to advancing professional development and her industry-specific insights make her a driving force in shaping the future of Medtech and Engineering in Ireland and beyond.Tune in for:The number one transversal skill you need to succeedMust have digital skills for the futureKey findings from Ibec's Talent to Thrive: The Future Skills Report for Ireland's Medtech Sector 2024 – 2028And much more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Listen in to not one but several fantastic MedTech leaders share their career stories and lessons in this special Future Leader Sessions episode of Career Diaries. This session - Managing and Motivating Others - covers:Setting goals and objectivesManaging performanceEngaging and motivating your teamInspiring trustEffective communication Our fantastic panel features:Serge TabetRegulatory Affairs Director EMEA at Terumo BCTNeelu GibsonWW Vice President, Regulatory Affairs, MDS at BDAndrea SpartiHead of QA/RA & Solutions Diabetes Care at Ypsomed AG Don't forget you can register for our Future Leader Sessions for free - just follow us on Linkedin to know when they're released > https://www.linkedin.com/company/elemed/ Prefer to watch the recording? Watch it for free here > https://www.elemed.eu/news-insights/future-leader-sessions-managing-and-motivating-others/Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Listen in to not one but several fantastic MedTech leaders share their career stories and lessons in this special Future Leader Sessions episode of Career Diaries. This session - Leading the Business Around You - covers:Partnering with the business; what stakeholders really wantGetting C-suite buy-inNetworking and building relationshipsInfluencing others Our fantastic panel features:Monika McDole-Russell Sr. Director, Global Regulatory Affairs at Medtronic Endoscopy Elizabeth GfoellerCorporate Director, Regulatory Affairs at MED-ELStefan FischerSVP Regulatory Affairs at Paul Hartmann AGKarim DjamshidiVice President - Global Patient Health & Regulatory Compliance at KARL STORZ SE & Co. KGDon't forget you can register for our Future Leader Sessions for free - just follow us on Linkedin to know when they're released > https://www.linkedin.com/company/elemed/ Prefer to watch the recording? Watch it for free here > https://www.elemed.eu/news-insights/future-leader-sessions-leading-the-business-around-you/Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Günter joined Tecan in 2003 as Senior Vice President, Head of Quality Assurance and Regulatory Affairs. He has been a member of the Management Board from 2003 to 2010 and a member of the Extended Management Board ever since.Günter has over 35 years of experience in the in-vitro diagnostics and medical device industry. He ensures successful strategies for commercialising products worldwide with his team and Tecan's customers. Günter is an expert in the implementation and certification of quality management systems in MedTech and IVD companies and a certified enterprise risk manager.Tune in for:How to adopt a business-first mindsetWhat QARA teams can do to build trust with business partnersHow to align QARA goals with the wider businessAnd much more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Listen in to not one but several fantastic MedTech leaders share their career stories and lessons in this special Future Leader Sessions episode of Career Diaries. This session - Looking Inwards - covers:Developing self-awarenessGetting and giving feedbackEmotional intelligenceVulnerability and authenticityContinuous self-improvement Our fantastic panel features:David Glasgow - Director of Quality, EMEA Commercial Operations at Bio-Rad LaboratoriesLacey Gigante - Director, Post Market Surveillance at Integra LifeSciencesFrederic Bustos - Senior Director RAQA Europe, Middle East, Africa, Latin America and Canada at StrykerRekha Roveri - Director Global Regulatory Affairs at Mozarc MedicalDon't forget you can register for our Future Leader Sessions for free - just follow us on Linkedin to know when they're released > https://www.linkedin.com/company/elemed/ Prefer to watch the recording? Watch it for free here > https://www.elemed.eu/news-insights/future-leader-sessions-looking-inwards/Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Patrice is a global leader in quality and regulatory with 30 years of international-related experience. He is currently the Vice-President, Quality Management and Regulatory Affairs at Sirona Medical. He works with teams to set up lean, sound, cost-effective business systems focused on client loyalty and growth.He helps companies determine the right investments to make so that quality and regulatory can become real competitive differentiators. He loves to coach, train and teach many. He draws inspiration from the Phillip B. Crosby quote: "Quality is free"Tune in for:Is it possible to be lean AND compliant?QA/RA and the futureWhat business leaders really want from their QARA partnersAnd much more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Julie is a serial innovator leveraging science, technology and creative communities to solve one of the biggest of society's problems - how to improve health. Spanning two decades of commitment to life sciences Julie has fused science, technology and business operations into new solutions that power the pharmaceutical industry. Partnership across peers, providers and academics has ensured that everyone has been part of this exciting journey.Tune in for:What MedTech can learn from big PharmaHow to implement digitisation into your businessThe impact of digital on jobs And much more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Jan is CEO & Partner at Qserve. He is an expert in European regulations based on 20 years hands-on working in the field, as auditor, product reviewer, regulatory specialist and senior manager. He combines strong experience in quality, compliance, and regulations with a pragmatic, result-driven approach at both operational and executive level.Prior to Qserve, Jan was VP Medical Devices at BSI for 5 years, where he was responsible for EMEA and AsiaPac and a member of the Executive Team. Before joining BSI, he was Business Director at KEMA (now DEKRA), responsible for their Medical Device and System Certification businesses globally.Tune in for:Education vs. experience - which matters most?The Rolls Royce strategyWhat it takes to transition from technical expert to business leaderLessons learned and advice for a younger selfAnd much more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Raina Dauria has been a leader in the Johnson and Johnson family of companies since 2003. She is currently the Vice President Global Regulatory Affairs Policy at Johnson & Johnson MedTech, where she provides dedicated focus on critical regulatory policy issues to shape new and emerging regulations globally. In addition to her policy responsibilities, Raina leads the Regulatory Talent Management Strategy and the MedTech R&D Learning Sponsorship, which drives the benchmark Culture of Learning at Johnson & Johnson. Raina is dedicated to nurturing diverse talent, sponsoring leadership development and diversity recruitment programs. Tune in for- Misconceptions about soft skill- Overcoming adversity in your career- The hardest feedback Raina ever had to hear- Mistakes people make on their way to the topAnd much more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Frédérique, a pharmacist with a Ph.D., has extensive experience in the pharmaceutical industry. She began her career with Novartis, gaining expertise in Operations, Quality, and Global Project Management. She later joined Edwards Lifesciences, where she held various leadership roles in Quality, eventually relocating to the US to lead Quality for Surgical and Implantable Therapies. She then moved to Becton Dickinson as Vice President International & Post-Market Quality, overseeing Quality Management globally. Frédérique is also dedicated to promoting women's advancement in leadership roles.Tune in for:Mastering the art of executive presenceTips for virtual executive presenceWhat makes great storytellingWhy practice makes perfectAnd much more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Dr. Bill Hunter is the Founding Member and CEO of Canary Medical, a medical datacompany focused on the development and commercialization of its patentedimplantable sensor technology and complementary data and analytics ecosystem.Bill brings more than 30 years of experience in healthcare as a former practicingphysician, serial medtech entrepreneur and chief executive. Bill holds a Doctorate ofMedicine from University of British Columbia, a Master of Science from University ofBritish Columbia and a Bachelor of Science from McGill University.Tune in for:Three honest lessons learnt from failingWhat it really means to be disruptiveHow company culture changes with growthAdvice on how to become a CEOAnd much more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Diana Saraceni is Co-Founder and General Partner at Panakes, a Venture Capital firm dedicated to early-stage investments in Life Sciences primarily in Europe and Israel. With over 20 years of VC experience, she has also co-founded and managed 360 Capital Partners. She has led investments in a significant number of companies all over Europe, not only in the Life Sciences sector, and generated several exits as IPO and M&A transactions. Diana is also part of several committees in Europe and in the US for public/private grants and awards allocation to start-ups. She also follows several portfolios in brain health tech. Tune in for:Insights into the current funding climateWhat VCs are looking for when they evaluate deals and the best way to ask for investmentTechnologies that are HOT right nowHow startups can really make moneyAnd much more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

In this special podcast, elemed's CEO and founder Elena Kyria speaks to Virginie Schwartz, Vice President Quality Assurance at Mölnlycke.Virginie is a Quality professional with 20 years' experience in medical devices regulations and 25 years' experience in highly regulated industries, with a strong sense for patients' safety and customers' satisfaction.In this celebration of all things Quality, Virginie shares insights on:- how to build a Quality culture- how to engage the whole company in Quality- why top-down buy-in is crucialAnd much more! ✨ Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Elemed is Europe's leading medical device and IVD recruiter.Struggling to find a perfect match for your position?Exploring new opportunities to catapult your career and find your dream job?Want to see more of our content? From behind-the-scenes videos to being the first to see new jobs being posted? Follow our LinkedIn!------Eric Klasen is the founder of Waypoint Life Sciences Consulting. Eric has had a diverse career spanning several decades, starting in Human Genetics research and progressing through various senior roles at organisations such as Serono and Novartis. After retiring as Vice President RA & Quality EMEA for Medtronic in 2019, he now consults for life sciences industry startups, serves on the boards of life sciences startup companies and the European Forum for Good Clinical Practice in Belgium, and is a member of the Supervisory Board of a group of Obesity Clinics (NOK) in the Netherlands. Tune in for:How to change the narrative and talk BUSINESSRA and the PR problemStrategies for connecting with other business functions and becoming an enablerAnd much more ✨Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Elemed is Europe's leading medical device and IVD recruiter.Struggling to find a perfect match for your position?Exploring new opportunities to catapult your career and find your dream job?Want to see more of our content? From behind-the-scenes videos to being the first to see new jobs being posted? Follow our LinkedIn!------Annette Brüls has served as CEO of Medela since May 2018. She has more than 20 years of experience in the medical device industry, having held a number of global leadership positions in several multinational companies. Annette has a lifelong fascination with the roles that innovation and technology play in improving our lives. As a woman leader of an organisation committed to women's health, and a mother and wife who has pursued career growth alongside motherhood responsibilities, Annette is personally dedicated to improving the opportunities available to mothers in the workplace.Tune in for:Insights into balancing a highly successful career and motherhoodDiscussion around why fewer women make it into leadership roles, despite more working in the industryHow companies can support mums who are returning to workAnd more ✨ Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Elemed is Europe's leading medical device and IVD recruiter.Struggling to find a perfect match for your position?Exploring new opportunities to catapult your career and find your dream job?Want to see more of our content? From behind-the-scenes videos to being the first to see new jobs being posted? Follow our LinkedIn!***Steve C de Baca is Executive Vice President and Chief Patient Safety & Quality Officer of Royal Philips as of February 2023 and brings more than 30 years of quality and regulatory affairs (QRA) experience in the medical technology industry.Additionally, Steve served as VP of QRA for Orthopedics and Americas for Zimmer Biomet, where he was responsible for supporting multiple business segments as well as the Americas region for international regulatory and compliance.Tune in toGain insights from advice offered to those apprehensive about career risks and blundersFind out how to strike a balance between risk and cautionExplore his approach to gauging the triumphs of taking risks...And so much more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Olga van Grol-Lawlor is an experienced Regulatory Affairs professional in the medical devices sector. She has over 10 years of experience and currently holds the position of Global Regulatory Intelligence and Advocacy Manager at Boston Scientific. Olga is actively involved in various industry groups and committees, representing Boston Scientific and participating in EU Commission meetings. She is also a frequent speaker at regulatory conferences and has a background in Equine Science.Join in to:Harness the significant power of self-awareness and its role in shaping personal values to create your own unique path.Find out more about the pervasive impact of imposter syndrome on individuals of diverse backgrounds.Embracing a proactive mindset, unearthing positive results, and showcasing the power of proactivity.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Suzie, the Vice President of Regulatory at BSI, has an impressive eighteen years of experience and currently develops strategies, policies, and processes for the Medical Devices team to ensure compliance with global regulatory requirements. She also represents all Notified Bodies as one of the Chairs of NBCG-Med and Vice-President of TeamNB. Tune in to find out the following!Her global traveling experience and how it enhances her ability to effectively communicate with companies from diverse countries and cultures.The advantageous role of Artificial Intelligence (AI) within the MedTech industry, while also highlighting the continued importance of human involvement.How fostering a flexible work-place environment has a positive impact on promoting a dynamic and adaptable environment.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Tom Melvin is Associate Professor of Medical Device Regulatory Affairs at Trinity College Dublin. Prior to his current role, he worked for HPRA and as a medical doctor. This episode looks at his fascinating career journey and delves into the inside scoop of going from working at a Competent Authority to academia.Tune in to learn about:What is working in a competent authority really like?Major regulation changes and evolutionsTaking the leap into academiaThe future of medical device regulations and the impact of AIAnd much more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Mario is SVP RA/QA at Bio-Rad Laboratories and has witnessed first-hand the medical device industry evolving over the past 30 years. He is extremely knowledgeable when it comes to building a successful culture of quality.Tune in to this episode to find out how to develop a winning culture of quality yourself!He covers:Culture of quality - a definitionMeasuring a culture of quality - key KPIs and metricsKey steps to building a good culture of quality What does a bad culture of quality look likeActionable tips for improving the culture of quality at your own companyAnd more!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

This special episode of Career Diaries by Elemed is for International Women's Day 2023 and is about Leading Inclusively in a Global Environment.Featuring Meg Mucha of Philips, Andreas Stange of TÜV SÜD, Kristine Tucker of Bausch & Lomb, and Matthew Schabacker of BD.Listen to their insightful perspectives!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Ondina is a Senior Director of Regulatory Affairs at Becton Dickinson, and has a wealth of experience leading teams and succeeding in the Medtech industry. In this episode, she discusses a topic that can really help you get ahead in your own career: visibility and exposure!She covers:What are visibility and exposure and why are they crucial?Is it more important for women to be visible?Top actionable tips on how you can start becoming more visible at your companyDos and don'ts of being visible in your organisationOndina's key learnings and success storiesAnd much moreCareer inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:How to bring Quality into leadership discussionsThe art of aligning members of your teamAvoiding communication mistakesGetting Quality to not be seen as the 'police'And more!About Paul Belgrove:Paul Belgrove is British by birth, but moved to Switzerland in 2008 and now has Swiss nationality. He is a chemist by profession and, with brief sojourns into other industries, has worked for more than 30 years in the medical device and pharmaceutical world. He has worked for some small enterprises and also for the biggest players in the industry including, Nycomed-Amersham, GE Healthcare, Cardinal Health and most recently Becton Dickinson. Paul has worked in Quality and Regulatory departments including as a Qualified Person. In addition to QA/RA roles he has worked in Operations and IT leadership positions. He believes this experience helps give him a more rounded outlook and helps him to be a business focused Quality professional. Over the years he has built and managed large global teams and is most proud of successes developing individuals to reach their highest potential within high performance teams. Today Paul is working independently, leveraging his skills and experience to support Med.Tech. SMEs manage their way through business “inflection points” such as scale-up, market access, or regulatory compliance challenges.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:Leadership pillars from a skilled leaderThe art of building teamsHow a sales and marketing background can be useful in the world of medical devicesAnd much more!About John Wilkinson:John retired from his role as Director of Devices at the UK Medicines and Healthcare products Regulatory Agency in October 2019 after 7 years in the role. During this period, he acted as chair of the Competent Authorities Medical Devices network in Europe and led the establishment of the Joint Action on Market Surveillance (JAMS) which was a collaborative programme supporting the implementation of the Medical Device Regulations and better working across the network.John was elected as Chair of the Board of Trustees for the Global Medical Devices Nomenclature in 2019, a position that he still holds whilst advising a number of organisations engaged in health policy, devices innovation and regulation.Earlier, John was Chief Executive of Eucomed, the leading European medical device industry representative body, and Director General of the Association of British Healthcare Industries (ABHI). These followed extensive industry experience in sales and marketing and general management with Becton Dickinson and the BOC Group as well as a period as chief executive of early stage medical imaging company.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:Learn about IVDR from MR IVD himselfWhy we can all be INSPIRED by the healthcare industryThe VALUE of having a hands-on backgroundWhy you should find your DRIVE from unlikely sourcesAbout Steve Lee:Steve joined ABHI as Director of Diagnostics Regulation in 2020.After completing his degree in Biochemistry and Biology at Aston University, Steve trained as a Biomedical Scientist, working in hospital microbiology before moving to industry to work as company microbiologist. Steve joined MHRA in 1996 when it was still the Medical Devices Agency and when the IVD Directive had yet to be implemented.While at MHRA, Steve worked with manufacturers, Notified Bodies, other Competent Authorities, Trade Associations, standards bodies, and government departments. Steve was Chair of the European Commission's IVD working group when the IVD regulations were being developed.In 2019, Steve was presented with the TOPRA award for regulatory excellence.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:Hear about Bassil's UNIQUE career path to successWhy it's crucial to be DECISIVE in lifeWhy you must accept some RISK in every ventureThe IMPORTANCE of leaving your comfort zone in industry About Bassil Akra:Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company which was founded in 2021 to support the various stakeholders in the healthcare system in achieving their targets in a highly regulated business area. He spent the last year consulting and supporting medical device, in-vitro diagnostic and combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Before that, he spent many years as a subject matter expert at the biggest notified body in Europe acting in various roles and representing locally and globally the notified body association in the various European discussions and guidance documents preparation. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standard. He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:How to find and understand your WHYGreat lessons in how to SUCCEED in Regulatory AffairsWhy connecting over food can be a POWERFUL way to build a rapport with someoneWhy MONEY shouldn't be your biggest driving forceAbout Donielle Johnson: Donielle Johnson is the Executive Director, Global Head Regulatory Affairs-Medical Devices for Bausch Health. In this role, Donielle leads the creation of a global medical device organization that supports strategic priorities domestic and internationally ensuring access to innovative technology and compliant maintenance of business. She partners closely with stakeholders across Medical Devices and represents Bausch Health in various internal and external forums with regulatory bodies, health authorities and trade associations. Donielle leads a dedicated team that will work collaboratively to ensure consistency in global medical device policy-shaping activities. Prior to Bausch Health, Donielle was the Sr. Director of Regulatory Affairs for EMEA & Canada Johnson & Johnson. In this role, she was responsible for leading a team of ~70 people to ensure compliant and on-time launches of new products, lifecycle management and business transformation, and policy shaping to drive regulatory harmonization.Prior to Johnson & Johnson, Donielle held several global roles with major medical device companies such as Philips, Abbott Vascular, and Medtronic. Leading teams through challenging premarket approvals; such as PMAs, 510(k), Health Canada approvals, and MDD Design Dossier approvals. Additionally, Donielle has extensive experience in lifecycle management and leading major manufacturing site change projects, resulting in several millions of annual savings for the company. Her career has spanned several countries including the U.S, Japan, and the Netherlands where she has lived since 2014. Donielle holds a BS in Chemistry and Biology from Howard University. She is currently pursuing a graduate degree in Global Health Policy at the London School of Hygiene and Tropical Medicine. Donielle is originally from New Orleans but currently resides in Amsterdam. Her hobbies are travelling, cooking, and the arts. She lives by the motto: To whom much is given, much is required; and is a mentor with SMDP providing guidance to minority graduate students in the biomedical field.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:Learn about Liam's EPIC comeback journey to successThe VALUE of being able to start from scratchThe art of PRIORITISATION and why this is neededWe can all be INSPIRED by Liam's career journeyAbout Liam Turley:Liam is the CEO and Quality Expert at Trinzo and is based in Galway, Ireland. Liam brings deep executive experience in quality and regulatory strategy and improvements, with a track record of comprehensive quality performance improvement.Liam has worked with the medical device and pharmaceutical industry for over 25 years, including with companies such as Tyco Healthcare, Mallinckrodt, Covidien and Medtronic. Prior to founding Trinzo, Liam was a global vice president of quality assurance with Medtronic. Liam has worked and lived in the United States and the Netherlands and has managed teams globally. Liam has led global initiatives in the area of medical device and combination products.​Liam has expertise in the area of quality remediations and leads companies successfully in resolving notified body major/critical findings, 483s, warning letters and consent decrees. Liam also has extensive MDR expertise and understands the client's needs for a pragmatic approach. He has liaised with multiple notified bodies, competent authorities, the FDA, and ministries of health around the globe.Liam holds a bachelor's degree in microbiology and an MSc in biotechnology, in addition to a postgraduate diploma in pharmaceutical manufacturing.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:Learn how to SEIZE the opportunities that scare you the mostWhy you should take on CHALLENGES as early as possible in your careerThe VALUE in networking rigorouslyMake your HEALTH a priority in work life About Kimberly Trautman: Kimberly A. Trautman is an experienced Medical Devices, InVitro Diagnostics, and Combination Product Expert with over 30 years of experience. She worked at the US Food and Drug Administration (FDA) for 24 years and continues to work with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience.Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes several medical device regulatory services and developed a formal Education/Training business. Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation. Expert in global medical device regulations, wrote and harmonized the current US FDA Quality System Regulation and was on the international authoring group of ISO 13485 since inception. Conceived and developed the Medical Device Single Audit Program and its consortium of five Global Regulators. Twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF). Recognized International Medical Device expert with a Master's Degree in Biomedical Engineering. Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:How to be a SUCCESSFUL serial entrepreneurWhy it pays to have a fascination with product SOLUTIONSHow the next great IDEAS are formedWhat INSPIRES Max and what we can all learn from thisAbout Max Boysset :Max has founded several companies. He has been the CEO of IcosaMed since 2019 and the CEO of SAV-IOL since 2014. In 2014 he also co-invented Sterilux. He is fascinated by product idea solutions and is what we can call a "serial entrepreneur". Max's experience stretches from big international companies to creating start-ups. He has 20 years' experience as an industrial pharmacist (PhD) with proven track records in the pharma, bio-pharma, and medical device sectors.For him, being a successful entrepreneur is getting the balance right between knowledge, experience and (potential) initiatives. According to Max, what you need to be an entrepreneur is: courage, effort, determination, uncompromising behavior, accepting failures, accepting support, the ability to cope with loneliness, humility, and BEING YOURSELF!Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:Learn the SECRET to managing and balancing your prioritiesThe key to success behind an INNOVATIVE companyFour important LESSONS learnt from board membership at a companyHow a start-up with ZERO financial backing managed to THRIVEAbout Christian Fredrik Stray, co-founders & CEO of Hy5:Christian has been the co-founder and CEO at Hy5Pro AS since 2015. Hy5Pro is a Norwegian medtech company developing the world's first hydraulic actuated hand prosthetic. Christian knows the secret to managing his priorities between being a father, socialising with family/ friends, doing outdoor activities and running a business. His vision of leadership is: to create and develop sustainable companies, through talented and motivated team members, which deliver value to owners and society. Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:How a different background can ENRICH your perception as a Regulatory Affairs professionalDISCOVER the thin divide between Management and Regulation in Medtech and why it mattersThe BEST piece of advice that Thomas received in his careerWhy you should be focused on the BIG PICTUREAbout Thomas Meininghaus, VP RA at Ottobock:Thomas has been the Vice President for Global Regulatory Affairs at Ottobock since February 2019. He's in charge of their Legal Manufacturer as well as 200 Patient Care Clinics.He is a highly regarded, visionary and culturally sensitive business executive. Combining his engineering background (PhD) with strong commercial and quality expertise, he has a demonstrable track record of developing and implementing business strategy for medical device organisations in both the corporate and SME environment. Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:Why you should prioritise CULTURE when starting a companyLearn the secret to a successful BUSINESS PARTNERSHIPHow to be IN TUNE with your workalike balanceWhen it's right to LEAVE YOUR JOB and become a consultant or start a company About Maria Fagan, President, RQM+ :Maria provides leadership to RQM+, ensuring the team is strategically focused on business balanced growth, the RQM+ vision and mission are upheld, and RQM+ is poised for success. Having cofounded R&Q in 2008, which was rebranded to RQM+ in 2020, Maria has an expert understanding of the consulting industry as well as the medical device industry. Maria has nearly 30 years of industry experience in medical device development across RA/QA areas, as well as post-surveillance and compliance. Maria capitalizes on this experience to ensure that RQM+ continues to provide top quality strategic and tactical solutions to the industry. Prior to co-founding R&Q, Maria held positions at MEDRAD, a two-time Malcolm Baldridge winning company and one of Pittsburgh's top medical device companies. Maria's previous positions included Director of Quality Assurance and Regulatory Affairs for Europe, as well as Manager of Quality Assurance for New Products where she led a team of professionals that provided a broad range of quality and regulatory services to product development teams. Maria holds an Executive Leadership Program certificate from Carnegie Mellon University's Tepper School of Business and a B.S. in Mechanical Engineering from the University of Pittsburgh.About Lisa Casavant, Executive VP, RQM+: Lisa cofounded R&Q in 2008, which was rebranded to RQM+ in 2020.  As a member of the executive leadership team, Lisa supports strategic planning and execution, and provides guidance across the company.  Lisa leads the RQM+ Marketing Team, focusing on creating and executing innovative marketing strategies to profitably increase revenue and grow the brand.  She is responsible for managing all aspects of RQM+ marketing campaigns and operations.  Lisa has 20 years of industry experience, with extensive expertise in medical device RA/QA and business development. Prior to co-founding R&Q, Lisa held positions at MEDRAD and the Tyco Healthcare. Lisa's previous positions included Senior Regulatory Affairs Specialist at MEDRAD, where she focused on worldwide submissions for product development teams and field safety risk assessments for product issues, and Process/Quality Engineer at the Tyco Healthcare Retail Group. Lisa holds an M.S. in Mechanical Engineering from the University of Delaware and a B.S. in Mechanical Engineering from West Virginia University.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:The secrets and success of a WOMEN-LED businessHow Elemed's Mentoring Academy was a GAME-CHANGERHow to use your passions and skillset to SUCCEEDElemed's EXCITING story and why you should start your own businessAbout Michelle:Michelle Lott is founder and principal of Lean RAQA Systems (leanraqa.com) where she has supported more than 100 companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services and grief counseling – because dealing with regulators can be emotionally draining.About Elena:Elena Kyria is an award-winning talent acquisition specialist in the Medtech industry. She has worked with hundreds of professionals in Regulatory, Quality and Clinical roles in Europe, over the last 9 years. In 2018, Elena was named one of the year's top Millennial Shepreneurs by Insights Success Magazine.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:Discover how to build WINNING teams in businessSelf-doubt and how you can CONQUER it and turn it into successCarolina's not-so-ordinary journey and how it can INSPIRE all of usTips on how to develop into a LEADERSHIP roleAbout Carolina: Carolina is a Neuroscientist and Business Executive with 15+ years of Medtech experience managing complex environments from acquisitions to consolidated businesses with P&Ls up to $140M all with high single to double digit growth % YOY. Head of Medtronic Deep Brain Stimulation for 10 years both as the European sales director and Global commercialization lead. Lover of value-based healthcare innovation leading to healthcare sustainability.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:Find out how to turn your passion into a PROFITABLE businessWhat is the optimal way to MANAGE a heavy workloadThe hottest upcoming TRENDS in the Medtech industryGREAT tips for starting a healthcare organisation and Medtech consultancyAbout Marissa:Marissa Fayer is a 20-year medtech executive, entrepreneur, and philanthropist. She is the CEO and founder of social enterprise / non-profit HERHealthEQ and the president of advisory firm Fayer Consulting LLC. Her mission is to move innovation and the health of women forward throughout the world through the advancement of organizations and the communities in which they operate by increasing investment, building world-class organizations and healthcare systems, and enhancing partnerships.  Marissa has previously served as an executive at Hologic, Olympus (formerly ACMI), Maquet-Getting (formerly Atrium Medical), Providien Medical, and Accumed Innovative Technologies.  Her consulting clients include several Top 500 companies and innovative start-ups including (but not limited to) Pfizer, the National Institutes of Health (NIH), Oerlikon AM Medical, Dometic, Asclepius Life Sciences Fund, Fisher Wallace, and Nuvasive.  Marissa sits on the board of medtech companies Welwaze Medical and DeepLook both focused on improving the diagnosis of breast cancer and PMD Medical focused on improving urinary incontinence.  Marissa graduated from Boston University with a BS in Manufacturing Engineering and with an MBA from the University of Connecticut.Marissa is a TEDx Speaker (2019 at TEDxLugano), and has been listed as one of the Top 100 Women in Medtech in 2018, a Top Woman Activist to Watch, awarded the 2018/9 Africa Development Award, a Wonder Women in Medtech in 2017, and has spoken at the World Alliance Forum, CapGemini Women of the West Forum, MPO Summit, DeviceTalks Boston and San Francisco, and many others. Marissa leads the #wealththroughhealth and #healthequityforwomen movements. Marissa lives in New York City and can be found at www.marissafayer.comCareer inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:Learn how to lead a company through a CUSTOMER-DRIVEN purposeFind out the UNIQUE strategy GN Hearing deployed to survive and thrive in the pandemicThe value of being PEOPLE-CENTREDWhy Gitte's favourite day is MONDAY About Gitte:Gitte is President & CEO of GN Hearing and a member of the executive management since 2019. She brings a unique set of capabilities and values to the Executive Management within international management, finance, IT, sales, and marketing in the medical sector as well as deep insights into building digital communities. Gitte Aabo's career since 1992 has taken her through diverse managerial positions including finance, IT, and general management. In 2001, Gitte was appointed CFO and Senior Vice President, Finances & IT in LEO Pharma; in 2005, member of the Executive Board; in 2007, Deputy Group Managing Director, and from 2008 to 2019 Gitte Aabo was President and CEO in LEO Pharma. Gitte holds an MBA from Copenhagen Business School, an HD graduate diploma in business administration as well as a bachelor's degree in economy.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:Philippe's take on the impact MDR has had on INNOVATIONHOT entrepreneurial advice for those of you thinking about starting your own companyPositive discrimination at Medtech startups - why you should be aware of thisShould you take the leap from company to STARTUPAbout Philippe:Philippe is a seasoned leader bringing 20 years of experience in the MedTech and Pharmaceutical industry.He started his career at Pfizer France, where he developed skills in Market Research, Market Access and Pricing. Philippe then joined Johnson&Johnson where he was in charge of Market Access for Ethicon Biosurgery for the EMEA (Europe, Middle East and Africa) region. Philippe joined Acclarent (J&J) and was in charge of setting up the business in France & Benelux.  He developed skillsets on the commercial development of new therapies. His scope of responsibilities extended to cover all pre-commercial markets in EMEA and lead the Professional Education team. Philippe then joined the New Ventures group at Livanova, where he supported disruptive internal projects and incubated startups. More recently, Philippe co-founded dianosic, a startup developing innovative solutions in the field of Ear, Nose and Throat, with a particular focus on epistaxis and chronic sinusitis, two areas with significant unmet medical needs.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:Learn the BENEFITS of being self-employed from an experienced consultantWhat is BRAND CONSISTENCY and why you need to be aware of thisHow to become an independent SUCCESS and start your own businessHow to GROW in the RAQA industryAbout Michelle:Michelle Lott is founder and principal of Lean RAQA Systems (leanraqa.com) where she has supported more than 100 companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services and grief counseling – because dealing with regulators can be emotionally draining. Her clients delegate all those things to her, so they can focus on winning in the marketplace! Michelle served a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP). She holds a BS in Chemistry from Troy State University and an Executive Leadership Certification in Regulatory Affairs from RAPS and Kellogg University. Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:How to SUCCEED in the first few crucial months as a founderDon't overlook it: the importance of NETWORKING effectivelyThe inside scoop: How Martha is playing her part in increasing the numbers of female founders and the funding given to themA FASCINATING career journey at what you can learn from itAbout Martha: Martha Lawrence is a Health Care Executive with more than 25 years of experience in leadership and operations with national health systems including Hospital Corporation of  America (HCA). Currently, Ms. Lawrence serves as CEO & Co-Founder of AccendoWave,  a machine learning health care technology company that objectively measures and manages pain/discomfort. AccendoWave has become the leading MedTech company in the US when it comes to measuring pain objectively and has partnered with two technology giants – Samsung and AT&T.Previously, Ms. Lawrence served as President of Sequoia Healthcare Advisors, an advisory firm providing strategic innovation and investment advisory guidance. Earlier Ms. Lawrence served in national account sales with Sandoz  Corporation (now Novartis) and in sales and marketing roles with National Medical Enterprises (now Tenet Healthcare).Martha Lawrence has a Master's of Business Administration from the University of Southern California and a Bachelor's of Science in Kinesiology from the University of California, Los Angeles.Ms. Lawrence serves as a board member for AccendoWave, Sequoia Realty Advisors and  American Healthcare Finance. Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:Learn from the master: How to develop GREAT communication skillsWhy should you PUSH yourself outside of your comfort zone? The great rewards it can lead toThe SECRET behind getting a job in something you have never done beforeHow to SUCCESSFULLY manage a team when you're the youngest person About Benoit: Benoit Clinchamps is President of MicroPort CRM since May 2018.As President of MicroPort CRM, Benoit Clinchamps brings more than 20 years of experience in the medical technology industry and 9 years of experience in the aerospace technology industry.Previously, Benoit Clinchamps served as Vice-President, General Manager for the CRM Franchise at LivaNova from July 2016 to April 2018, Vice-President for Product Development & Regulatory Affairs from 2013 to 2016, Vice President for Quality Assurance & Regulatory Affairs from 2009 to 2013, Plant Manager from 2006 to 2009 and Quality Assurance & Regulatory Affairs Director from 2005 to 2006.Prior to joining Sorin Group, Benoit Clinchamps spent 6 years at GE Healthcare and was 6 Sigma Champion for Europe Operations, Manufacturing Manager and 6 Sigma Black Belt. Prior to the healthcare and medical product industry, Benoit gained a thorough experience in the aerospace industry where he was Program Manager for international programs.Benoit holds an Engineering Degree from ICAM Lille France (Institut Catholique des Arts et Métiers, 1988). He furthermore completed a Management Course from ECATA (European Consortium for Advanced Training in Aerospace) in ENSAE Toulouse France (Ecole Nationale Supérieure de l'Aéronautique et de l'Espace) and in TUM Germany (Technische Universitat München). He is a certified 6 Sigma Black Belt. He also took an Executive Course at INSEAD Fontainebleau France. Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:The impact and importance of a strong MENTORLearn the SECRETS of Stefan's hiring processYou might be surprised by his CAREER-DEFINING moment! It isn't what you'd expectHow to become a good MENTOR yourselfAbout Stefan: After studying Plastic Engineering Stefan started work at a small tool shop and Injection Moulding company that supplied the automotive and electronic industry. He joined life science soon after and stayed in the industry ever since. Small family-owned businesses, to large enterprises and a start-up company, were stations in the last 30 years. He received a second diploma in Economics in parallel. Experienced mainly in Quality and Regulatory, but also in R&D, Operations, Health, Safety, Environment, Stefan's current position is SVP Regulatory Affairs for the Paul Hartmann AG in Germany.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:How to BUILD a successful Medtech company from scratchInvestor to CEO: Learn how to SCALE successAhead of the GAME: How to avoid common mistakes that Medtech startups makeBuilding a STRONG company culture About David:David Fischel has served as CEO and Chairman of Stereotaxis since February 2017. He joined Stereotaxis as a Director in late 2016 after orchestrating a transformative equity investment in the company. Mr. Fischel has served for over ten years as Principal and portfolio manager for medical device investments at DAFNA Capital Management, LLC. Prior to joining DAFNA Capital, he was a research analyst at SCP Vitalife, a healthcare venture capital fund. Mr. Fischel completed his B.S. magna cum laude in Applied Mathematics with a minor in Accounting at the University of California at Los Angeles and received his MBA from Bar-Ilan University in Tel Aviv. He is a Certified Public Accountant, Chartered Financial Analyst and Chartered Alternative Investment Analyst.Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development, and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:What does it take to become a successful FEMALE LEADER?How to RISE up the ranks in a male-dominated industryThe art of reinforcement: how giving (and receiving) constructive feedback can help you GROWOn everyone's mind: The importance of WORK-LIFE BALANCEAbout Erin:I am a commercial leader committed to driving growth and performance. My passion is developing commercial strategy and engaging talent across different geographies. I value collaboration and building teams of engaged employees that drive value across our organization.I have 16 years of intensive work across Europe and North America leading teams, identifying and developing talent.  My experiences are diverse from implant, capital and disposable businesses in both smaller ($50million) and larger ($1B) commercial organizations. I am a dynamic leader with proven results in sales, marketing, strategic planning, commercialization and business development.  I excel at working cross-functionally and across different geographies.  I joined Stryker in 2004 as a Marketing Associate in Instrument Division; in 2006 to 2009 I had a sales territory in Surgical where I grew the business from $2.1-$4.4 million.  In 2009, I moved to Stryker Europe, where I was UK Marketing Manager, Regional Sales Manager in the Medsurg and Spine Divisions and then was Director of Marketing for Europe.  I managed and drove the strategy for Mako Robotic Arm Assisted Surgery globally my role at that time comprised of leading and executing all aspects of the commercial strategy of a new innovative acquisition. Since then, I worked at Alcon, UK & Ireland leading a team of 65 across the $88m Surgical Eyecare portfolio.I graduated from the University of Colorado on an NCAA Division I Athletic and Academic Full Scholarship, completing a Human Physiology degree.  During my tenor at Colorado as team captain, became an All-American athlete, and was awarded the Buffalo Award of Distinction and the Leo Hill Academic Leadership Award.  Prior to University, I competed as an athlete on the Canadian Alpine Ski Team from 1997-1999.  In 2012, I graduated from Georgetown & Esade University, completing a Global Executive MBA, specializing in Globalization and Emerging Markets garnering experience in Russia, India, Brazil, Argentina, Spain, and the US.  In 2013, I was awarded the European Award of Excellence for Europe.I am currently engaged in my role at NuVasive as Commercial Vice President, Europe.  NuVasive's innovative technology and unique combination of spine implants and capital is key to me and I value direct involvement with the cross-divisional communication and engagement within the business.  Building relationships with customers our internal employees drive me and area where I would like to have the greatest impact. Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:What is the GOLDEN TRIANGLE for recruitmentHow to employ unicorns that will guarantee you SUCCESSWhy we all need to focus on building our PERSONAL BRANDThe art of ZEN: How yoga can positively impact successAbout Erik: Erik specialises in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.He actively contributes to law and policy development at national and EU level via membership of specialized committees at branch associations and the European Commission. Erik also works as arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation.Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Key takeaways:Learn about DISRUPTIVE technologies shaping the future of MedtechWhy AI won't take the role of doctorsTools for success from someone with GLOBAL leadership experienceHow working in the medical device industry affects how you see things as a PATIENTAbout Matthias: Mr. Buerger is the Vice President Regulatory Affairs and Quality Assurance EMEA for Zimmer Biomet.  He has a Master's of Science degree in Biomedical Engineering from Marquette University in Milwaukee, WI, as well as a Dipl. Ing. degree in Electrical Engineering from Fachhochschule Dieburg in Germany. In the past Mr. Buerger has had a variety of different management roles in Quality Assurance and Regulatory Affairs for companies including GE, Baxter, Terumo & Guidant. He has also worked as a Quality Management Systems and Operational consultant for Grant-Thornton, as well as spending time as a lead auditor and test engineer for TUV Rheinland, a European Notified Body. Mr. Buerger has spoken at a variety of international conferences, including RAPS, MD&D, ASQ, IEEE and others.  Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.