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Career Diaries by Elemed

Elena Kyria

Welcome to Career Diaries by Elemed, the podcast dedicated to careers in the MedTech industry. This podcast is all about hearing stories from some of the industry's most inspiring professionals and exploring their steps to success.


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Key takeaways:

  • How to find and understand your WHY
  • Great lessons in how to SUCCEED in Regulatory Affairs
  • Why connecting over food can be a POWERFUL way to build a rapport with someone
  • Why MONEY shouldn’t be your biggest driving force

About 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.

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Key takeaways:

  • How to be a SUCCESSFUL serial entrepreneur
  • Why it pays to have a fascination with product SOLUTIONS
  • How the next great IDEAS are formed
  • What INSPIRES Max and what we can all learn from this

About 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!

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Key takeaways:

  • Learn about Liam’s EPIC comeback journey to success
  • The VALUE of being able to start from scratch
  • The art of PRIORITISATION and why this is needed
  • We can all be INSPIRED by Liam’s career journey

About 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.

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Key takeaways:

  • Learn how to SEIZE the opportunities that scare you the most
  • Why you should take on CHALLENGES as early as possible in your career
  • The VALUE in networking rigorously
  • Make 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.

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Key takeaways:

  • Hear about Bassil’s UNIQUE career path to success
  • Why it’s crucial to be DECISIVE in life
  • Why you must accept some RISK in every venture
  • The 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.

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Key takeaways:
Learn the SECRET to managing and balancing your priorities
The key to success behind an INNOVATIVE company
Four important LESSONS learnt from board membership at a company
How a start-up with ZERO financial backing managed to THRIVE

About 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.

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Key takeaways:

  • How a different background can ENRICH your perception as a Regulatory Affairs professional
  • DISCOVER the thin divide between Management and Regulation in Medtech and why it matters
  • The BEST piece of advice that Thomas received in his career
  • Why you should be focused on the BIG PICTURE

About 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.

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Key takeaways:

  • Why you should prioritise CULTURE when starting a company
  • Learn the secret to a successful BUSINESS PARTNERSHIP
  • How to be IN TUNE with your workalike balance
  • When 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.

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Key takeaways:

  • The secrets and success of a WOMEN-LED business
  • How Elemed’s Mentoring Academy was a GAME-CHANGER
  • How to use your passions and skillset to SUCCEED
  • Elemed’s EXCITING story and why you should start your own business

About Michelle:
Michelle Lott is founder and principal of Lean RAQA Systems ( 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.

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Key takeaways:

  • Learn about IVDR from MR IVD himself
  • Why we can all be INSPIRED by the healthcare industry
  • The VALUE of having a hands-on background
  • Why 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.

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