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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.
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.
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.
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.
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.
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.
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. 
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!
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. 
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. 
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.
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.
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.
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.com
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.
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.
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. 
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. 
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. 
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.
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