About the Company - To support our strategic approval processes for medical devices as well as the registration of new products and the development of new markets, we are looking for a (Senior) Regulatory Affairs Manager Medical Devices. About the Role - These tasks await you: Regulatory advice and strategic support in the development of new medical device products Preparation of approval documents and coordination of European and international registration processes, for example according to EU-MDR or US-FDA 510(k) Creation and structured management of the technical documentation for our medical devices Implementation of regulatory and normative requirements in our product development projects Answering and supporting regulatory customer concerns Cross-departmental communication and regulatory advice Conducting and coordinating regulatory audits Monitoring and renewing our medical device approvals Ensuring the conformity of our products with the regulations of the respective regions Required Skills At least 4 years of experience in a regulatory affairs position and in the preparation of registration documents for medical devices is essential. Ideally experience in Class III (EU) medical device registration. Ideally also experience in FDA approval processes. Knowledge of biological/ animal tissue products/regenerative products would be beneficial, but not essential. Experience in creating and structuring technical documentation. Experience with and knowledge of regulatory guidelines and regulations. Proficiency in written and spoken English, German language skills are an advantage. Experience in project management with strong analytical skills as well as creativity and intuition desirable. Very good knowledge of MS Office. Structured and independent way of working.