Regulatory Affairs Manager
Core
Guide the business through the regulatory landscape for Class I and Class II medical devices and non-medical consumer products, ensuring compliance with external regulations and company safety policies to achieve successful market access.
Role type
Regulatory Affairs Manager
Builds
Medical device and consumer product groups
Domain
Medical devices and consumer electronics
Required skills
Regulatory submissions, Risk Management (IEC 14971), 510(k) clearance, EU MDR/MDA technical files, EUDAMED, UDI requirements, Technical writing, Project management
Preferred skills
Consumer product experience, System thinking
Technologies
EUDAMED, UDI
Responsibilities
Participate in Product Development Teams, Take ownership of regulatory submissions (initial registrations, changes, renewals), Prepare and maintain European Technical File for CE marking, Drive 510(k) clearance in the U.S., Work with test houses and notified bodies
Seniority
Mid-Senior, hands-on IC