Lead Regulatory Affairs Specialist (m/f/d)
Core
Ensuring medical devices meet regulatory requirements and managing submissions for market approval in the minimally invasive surgery domain.
Role type
Lead Regulatory Affairs Specialist
Builds
Medical device regulatory compliance and market access for minimally invasive surgery tools
Domain
Medical Devices / Minimally Invasive Surgery
Deliverable
client delivery
Required skills
Regulatory submission management, Design control process oversight, Risk management, Clinical evaluation, Usability file management, Quality management system (QMS) maintenance, Compliance with essential requirements, Technical documentation control, Regulatory evaluation of change orders, 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, Maintain QMS compliance
Seniority
Senior, hands-on IC