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

Job Summary

The Biocompatibility Specialist is responsible for ensuring the biological safety and performance of medical devices throughout their lifecycle. This critical role involves managing the design, planning, coordination, and monitoring of studies related to biocompatibility and toxicology, supporting both product development and post-market registration maintenance. Key daily tasks include creating Biological Safety Evaluation Plans and Biological Risk Assessments, and overseeing preclinical biocompatibility studies to ensure data quality, adherence to timelines, and budget compliance. Furthermore, the specialist provides essential support for market authorization, which includes drafting and reviewing complex regulatory submission documents such as IDE, BSEP, BSER, IND, eCTD, IB, IMPD, and toxicological assessments. The ideal candidate holds a degree in a natural science field and demonstrates strong organizational skills, precise working methods, and excellent written and verbal English proficiency.