Regulatory Affairs Manager (m/f/d)

A safe workplace in a company that develops, manufactures and distributes medical devices worldwide – making an important contribution to the health of many people Attractive Benefits such as Hansefit, Jobticket, JobRad and Occupational Careers A team that holds together, supports and shares knowledge A thorough introduction so you can quickly find yourself in your tasks

What's in your job Together with your colleagues, you actively strive to meet the legal and regulatory requirements for our products and processes - from market launch to the entire product life cycle.

Your duties include:

Coordination and implementation of our medical devices for international markets Development of regulatory strategies and plans for global authorisations Creation and testing of filing documents for the global approval of medical devices Contact persons for internal areas (R&D, product management, sales, international branches) and externally for authorities Active cooperation in development projects Monitoring and maintenance of the global approval status of our products, as well as care in internal systems and regular reporting Support for internal and external audits

Successfully completed technical or scientific studies – alternatively a comparable qualification with relevant professional experience Multiannual experience in Regulatory Affairs in Medical Technology Knowledge of regulatory requirements (e.g. MPDG, MDR), and relevant standards such as ISO 13485, ISO 14971, IEC 60601-1/2, IEC 62304 Experience in the production of technical documentation for international authorisations Project management experience Good to very good knowledge of German and English in word and writing Secure handling of MS Office, especially Word and Excel