Career Diaries by Elemed Elena Kyria

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 definition
Measuring a culture of quality - key KPIs and metrics
Key steps to building a good culture of quality 
What does a bad culture of quality look like
Actionable tips for improving the culture of quality at your own company
And more!

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!

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 more

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 sources
About 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.