Regulatory Affairs Manager - Medical Device
Core
Oversees the regulatory process for medical devices and marketing authorizations, managing government interactions, inspections, and compliance strategies.
Role type
Regulatory Affairs Manager
Builds
Medical Device regulatory filings and marketing authorizations
Domain
Medtech, Digital Health
Deliverable
client delivery
Required skills
Regulatory strategy development, Technical File creation, clinical investigation management, post-marketing surveillance, international regulatory coordination
Preferred skills
Doctor of Medicine MD, third language proficiency
Technologies
Microsoft Office (Outlook, Word, Excel, PowerPoint)
Responsibilities
Collaborate on regulatory strategy implementations for Medical Devices, manage Technical File creation and updates, support clinical investigation management and documentation, manage post-marketing surveillance activities, supervise international regulatory and quality activities
Seniority
Manager, strategic oversight & coordination