Manager Regulatory Affairs (m/f/d)
Core
Manage regulatory submissions and approvals for medical devices to ensure timely market placement and compliance throughout the product lifecycle.
Role type
Manager Regulatory Affairs (Medical Devices)
Builds
Medical device products (cameras, insufflators, pumps, tubing) for minimally invasive surgery and advanced manufacturing.
Domain
Medical Devices / Healthcare Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory affairs expertise, medical device industry background, technical and disciplinary management, resource and budget planning, quality management system (QMS) maintenance, safety incident management, cross-functional coordination
Preferred skills
Experience as a manager, innovation process initiation
Technologies
None stated
Responsibilities
Manage compilation of approval documents and declarations of conformity; Interface with customers, notified bodies, and authorities; Manage safety-related complaints; Coordinate audits; Maintain QMS processes
Seniority
Manager, hands-on leadership