The company is seeking for a Regulatory Affairs Manager. Responsibilities Responsibility for researching requirements, as well as planning, implementing, coordinating and monitoring international registrations of our products (Medical + IT) Implementation of the applicable regulatory requirements of the target markets in the company Continuous monitoring of changes in the regulatory requirements applied in the target markets Compilation of the necessary documents in cooperation with specialist departments, timely submission of documents to authorities for new registration and extensions Central contact for regulatory-relevant matters of international authorities or approval partners, as well as for internal company departments Testing and evaluation of product conformity (medical devices, IT products) with regard to regulatory (FDA, MDR, TGA…), technical requirements (GPSR, EMC, LV…) and environmental requirements (RoHS, REACH, POP, battery, packaging, return…), as well as release of product files Testing and evaluation of product changes relevant to approval Participation in product development projects Creation and updating of process descriptions and templates in the work area Post-market research and surveillance on relevant databases Profile Completed studies (technical, medical, scientific) or comparable training and experience Additional qualification as Regulatory Affairs Manager Kentnisse to DIN ISO 13485, ISO 9001, ISO 14001, ISO 27001 Sound expertise in the national and international approval of medical and IT products (including MDR, FDA, TGA, ANVISA, SFDA, CQC…), experience in conformity assessment procedures, very good knowledge of the relevant product standards (IEC14971, IEC 60601, IEC 62368, IEC 62304, IEC 81001-5-1…)