Specialist Regulatory Affairs (m/w/d)

As an owner-managed family company, we develop, produce and distribute high-tech surgical technology worldwide. Through our forward-looking corporate management, we drive forward medical progress and live values such as trust, respect and openness. This is the basis of our success. For our location in Tübingen we are looking for quality and approval management Specialist Regulatory Affairs (m/w/d)

Preparation and updating of the technical documentation of medical devices according to MDR 2017/745 Responsibility for compliance with applicable regulatory requirements (e.g. MDR 2017/745, IEC 60601-1, IEC 62366-1, ISO 14971) Preparation of test plans, organisation of tests and definition of test characteristics and test equipment to be used Conducting electrotechnical and mechanical standard tests (e.g. leakage current and stress resistance tests) and compiling the associated evidence Compilation of standard test reports to demonstrate compliance with standards Contact person of the designated body for the testing of technical documentation and for regulatory issues arising from development and production Establishing approval strategies for the approval of medical devices

Successfully completed electrotechnical or mechatronic training with a further education to the technician or successfully completed technical studies with the field of electrical engineering, mechatronics or comparable qualification First professional experience in conducting electrotechnical tests Ideally, first professional experience in quality/accreditation management as well as in the approval of medical devices in a medical technology or pharmaceutical company Good knowledge of QM systems and regulatory requirements in medical technology (e.g. MDR 2017/745, IEC 60601-1, IEC 62366-1, ISO 14971) High sense of responsibility and a structured and analytical way Good knowledge of German and English in word and writing

Ergonomic jobs with the most modern equipment Width, regional canteen offer with breakfast, lunch and free drinks (water, coffee) Good reconciliation of family and profession through support for holiday care and external counselling services for all living situations Attractive monthly compensation with special tariff and extra-tariff payments (Christmas money, holiday money etc.) Working time account for a certain chronological flexibility and possibility for hybrid work Wide range of internal and external training and support for further and further training Job in a family-run company in a crisis-proof industry JOBV1_EN