Director, Regulatory Affairs, Europe
Core
Lead European Regulatory Affairs strategy for medical device product launches, premarket submissions, and postmarket compliance.
Role type
Director, Regulatory Affairs
Builds
Regulatory strategies and compliance frameworks for GE HealthCare's medical device portfolio
Domain
Healthcare / Medical Devices
Deliverable
client delivery
Required skills
EU MDR, UK MDR, regulatory submissions, CE/UKCA marking, stakeholder engagement, team leadership, strategic planning
Preferred skills
IVD regulatory expertise, SaMD knowledge, global matrix organization experience
Technologies
None stated
Responsibilities
Lead and develop the European Regulatory Affairs team; Define and execute regulatory strategies aligned with global objectives; Ensure compliance with EU MDR and other applicable European regulations; Oversee regulatory submissions, CE / UKCA marking processes, and interactions with Notified Bodies and Competent Authorities; Monitor regulatory changes and assess impact on product portfolio; Collaborate with Quality, Legal, Commercial, and Product teams to ensure regulatory alignment
Seniority
Director, strategic leadership & team management