Fellow, Regulatory Affairs
Core
Strategic leadership in navigating the evolving U.S. medical device regulatory landscape and strengthening relationships with European Notified Bodies.
Role type
Senior Regulatory Affairs Fellow (Strategy & External Engagement)
Builds
Strategic regulatory policy, intelligence, and external engagement initiatives for enterprise-wide Notified Body collaboration.
Domain
Medical Devices / Regulatory Affairs / EU MDR / US FDA
Deliverable
dashboards & analysis
Required skills
Regulatory strategy, policy interpretation, external regulatory engagement, EU MDR compliance, FDA regulations, Notified Body governance, stakeholder influence, industry advocacy
Preferred skills
Cross-functional leadership, negotiation, executive presentation, strategic thinking
Technologies
None stated
Responsibilities
Serve as primary corporate liaison with European Notified Bodies (BSI, DEKRA, TÜV, GMED); Lead enterprise-wide Notified Body governance and performance monitoring; Monitor U.S. FDA regulatory developments and analyze business implications; Develop regulatory policy positions and advocacy strategies; Represent the company in industry associations and regulatory working groups; Collaborate with Quality, Legal, and Government Affairs teams to align regulatory initiatives.