Biocompatibility Specialist | Biocompatibility Specialist (m/w/d), Achenmühle

Job Summary

The Biocompatibility Specialist will be responsible for planning and commissioning biocompatibility tests and conducting biological evaluations according to EN ISO 10993. This role involves close collaboration with various departments, especially Research & Development and Product Management, to ensure the biocompatibility of medical devices. Key responsibilities include supporting product registrations both domestically and internationally, developing biocompatibility strategies, and responding to inquiries from national authorities like the FDA, PMDA, EU, and NMPA. The specialist will also contribute to implementing product changes and new requirements from updated EN ISO 10993 standards, maintain technical documentation in compliance with MDR (EU) 2017/745 and EN ISO 13485, and assist with audits. This position offers an opportunity to work in a dynamic, innovative, and growing medical technology company.