Lead Regulatory Affairs Specialist (m/f/d)
Core
Ensures medical devices meet regulatory requirements and manages timely submissions/approvals for market placement.
Role type
Lead Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory compliance documentation and market access for minimally invasive surgical devices
Domain
Medical Devices / Minimally Invasive Surgery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission management, Design control process management, Risk management, Clinical evaluation, Usability file management, Technical documentation control, Compliance assessment, Change order evaluation, Notified body interface, Safety incident processing
Preferred skills
Advanced training in Manager Regulatory Affairs for Medical Devices
Technologies
None stated
Responsibilities
Compile approval-relevant documents (certificates, legalizations), 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