Finding your path in unexpected places | Bassil Akra, CEO and Owner at AKRA TEAM GmbH

12/10/21 • 42 min

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.

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 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

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.

Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

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undefined - Finding purpose to life, work and everything in between | Donielle Johnson, Executive Director, Global Head Regulatory Affairs-Medical Devices at Bausch Health

Finding purpose to life, work and everything in between | Donielle Johnson, Executive Director, Global Head Regulatory Affairs-Medical Devices at Bausch Health

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.

Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

Next Episode

Developing skills in the last place you'd expect | Steve Lee, Director of Diagnostics Regulation, ABHI

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.

Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.