Donielle Johnson is the Global Head of Regulatory Affairs for Baxter’s Advanced Surgery business.
Donielle leads a global regulatory affairs organization that supports strategic priorities across biologics and medical devices: ensuring access to innovative technology with compliant and on-time new product launches, maintenance of business, lifecycle management, and policy shaping initiatives to drive regulatory harmonization. She partners closely with stakeholders within Advanced Surgery to create regulatory strategies that are in line with business objectives and represents Baxter in various forums with regulatory bodies, health authorities and trade associations.
Prior to Baxter, Donielle held several global roles with increasing responsibility at Bausch & Lomb, Johnson & Johnson, Philips, Abbott Vascular, and Medtronic. She has led teams through challenging premarket approvals (i.e. PMAs), major shifts in regulatory framework (i.e. EU MDR), and complex post market changes (i.e. complex manufacturing site moves). Her career has spanned several countries including the U.S, Japan, and the Netherlands. Her passion is the delivery of global innovation with the least burdensome approach. She believes everyone, no matter their socioeconomic status, should have access to the best medical technology.
Donielle holds a BS in Chemistry and Biology from Howard University in Washington, DC and is currently pursing a masters in Global Health Policy at the London School of Tropical Medicine.