Regulatory Affairs Specialist (Medical Devices) | Biologe (m/w/d)

Job Summary

This position is within an innovative, traditional German medical device company focused on providing optimal solutions for medical professionals globally. The Regulatory Affairs Specialist will be integral to ensuring compliance and market access for medical devices worldwide. Day-to-day responsibilities include creating and updating Technical Documentation according to the MDR for generic product groups (non-active and active medical devices up to Class IIb). The specialist will manage the compilation, submission, and maintenance of country-specific approvals and registrations, requiring frequent communication with internal departments, external partners, and international regulatory authorities (such as FDA, NMPA, and ANVISA). Success in this role requires a completed scientific or technical degree, coupled with five years of professional experience in medical device regulatory affairs and strong expertise in national and international regulations (MDR, ISO 13485, MDSAP).