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.