Lead Regulatory Affairs Specialist Medical Devices (m/f/d)
Core
Ensuring medical devices meet regulatory requirements and managing submissions for market approval.
Role type
Lead Regulatory Affairs Specialist
Builds
Medical devices for minimally invasive surgery (cameras, insufflators, pumps, tubing)
Domain
Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory submission management, Design control process management, Risk management, Clinical evaluation, Usability file management, Quality management system (QMS) compliance, Technical documentation control, Declaration of conformity preparation, Regulatory evaluation of change orders, Audit support coordination, Safety incident processing
Preferred skills
Advanced training in Manager Regulatory Affairs for Medical Devices
Technologies
None stated
Responsibilities
Compile approval-relevant documents and declarations, Control technical documentation for conformity assessment, Support design control and risk management processes, Interface with customers, notified bodies, and authorities, Process safety-related complaints, Initiate and monitor QMS measures
Seniority
Senior, hands-on IC