Manager Regulatory Affairs

Working at Freudenberg: We will wow your worldResponsibilities:You contribute to the further development of Regulatory Affairs and quality management systems in accordance with MDR and ISO 13485You coordinate international approval and registration procedures for medical devices containing medicinal componentsYou prepare and maintain technical documentation and communicate with customers, suppliers, and authorities worldwideYou handle regulatory authority inquiries and research country-specific approval requirementsYou support R&D, production, and logistics in matters of regulatory compliance and qualityYou maintain change management processes and support design and process changesYou prepare and conduct audits, including communication with customers and authoritiesQualifications:You hold a degree in natural sciences, biomedical engineering, or a comparable qualificationYou have experience in the medical device industry, ideally also in the validation of sterilization processes (ETO)You are familiar with regulatory requirements for medical devices in the EU (EU MDR, ISO standards, MPDG); knowledge of pharmaceutical regulations (AMG, GMP) and international standards (US FDA) is an advantageYou have a good understanding of medical devices and functional pharmaceutical coatingsYou work independently, in a structured manner, and as part of a teamYou are proficient in MS Office, Adobe Acrobat, and quality management systems according to EN ISO 13485You have excellent written and spoken German and English skills