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

Job Summary

This role involves taking responsibility for assessing the biological safety and performance of medical devices within the pharmaceutical and life science sectors. The Biocompatibility Specialist will manage the design, planning, coordination, and monitoring of activities supporting product development and lifecycle management, specifically focusing on biocompatibility and toxicology. Key tasks include creating Biological Safety Evaluation Plans (BSEPs) and Biological Risk Assessments, managing preclinical biocompatibility studies, and ensuring data quality, schedule adherence, and budget compliance. A crucial part of the job is supporting market authorization by preparing regulatory documents (e.g., IDE, BSEP, BSER, IND, eCTD) and reviewing/updating existing documentation to maintain post-market registration. The ideal candidate holds a scientific degree (e.g., Biology, Biochemistry, Pharmacy) and possesses strong English communication skills, a precise working style, and good time management capabilities.