Regulatory Affairs Manager (m/w/d)

As an innovative and internationally oriented manufacturer of premium implants for eye surgery, we develop, produce and distribute medical devices to give the human eye the best possible visual force. To strengthen our team at the Erlangen site, we are looking for a full-time REGULATORY AFFAIRS MANAGER (M/W/D)

Approval and registration of medical devices in national and international markets Preparation of documents for certification and legalisation Support for the care and cooperation in the production of technical product documentation including risk management files and certification-relevant documents within the framework of international authorisation strategies Project support for the implementation of the requirements of the new EU Medical Device Regulation and support in maintaining the appropriate authorisations Contact person internally and for business partners on regulatory issues Regulatory evaluation of product and document changes relevant to authorisation Support in the revision and creation of RA-relevant QM documents Support in ensuring compliance with all policies, laws and standards and country-specific requirements Search of guidelines and laws Close internal communication and coordination with other departments

Successfully completed studies of engineering, medical technology or a scientific field At least 3-5 years of experience in product approval of medical devices in the regulatory field Knowledge of regulatory requirements (MDR, MDD, FDA, NMPA, EN ISO 13485, EN ISO 14971) for non-active medical devices Knowledge of risk management Ophthalmological knowledge of advantage Safe handling of MS Office Very good knowledge of German and English Loadability in case of severe work accident Structured, solution-oriented and independent operation Teamability and enforcement Embossed service orientation, friendliness and professional ways of handling

Varied and responsible activities in an innovative and forward-looking company Independent task Exchange at eye level Collaborative Support Culture Short decision paths due to a flat hierarchy Family friendly 30 days holiday per year Christmas and holiday money JOBV1_EN