Direktvermittlung: (Senior) Specialist (m/w/d) Regulatory Affairs
Core
Creating and maintaining technical files for medical devices, acting as the liaison for regulatory authorities, and managing global regulatory changes for a surgical laser company.
Role type
Senior Regulatory Affairs Specialist
Builds
Regulatory compliance and product registration for surgical lasers
Domain
MedTech / Surgical Lasers
Required skills
Regulatory Affairs, MDR compliance, Change management, Product registration (CE/International), Audit support, Technical file management
Preferred skills
Active medical devices, medical software, single-use medical devices
Technologies
MDR, CE, UDI
Responsibilities
Create and maintain technical files per MDR, Serve as contact for notified bodies and authorities, Monitor and evaluate regulatory changes globally, Support product registration on CE and international levels, Represent regulatory matters in company projects, Support internal and external audits