Regulatory Affairs Manager
Core
Provides strategic regulatory leadership for Invasive Cardiology programs, managing global premarket submissions, registrations, and post-market compliance for medical devices.
Role type
Senior IC Regulatory Affairs Manager (Medical Devices)
Builds
Global regulatory strategies and product registrations for new device introductions
Domain
Medical Devices / Invasive Cardiology
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory strategy, premarket submissions, device classification, risk management, post-market reporting, advertising review, product labeling compliance, project management, regulatory intelligence
Preferred skills
Advanced degree in scientific/regulatory fields, RAPS certification, specialized expertise in own discipline
Technologies
None stated
Responsibilities
Develop global regulatory strategies for new product launches, assess product changes for license/registration needs, review and approve promotional materials, lead regulatory inspection support and inquiry responses, serve as a best practice resource for the team
Seniority
Senior, hands-on IC with strategic influence
