Career Diaries by Elemed

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.

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!

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.

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.

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.