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

Job Summary

This role involves taking responsibility for the biological safety and performance evaluation of medical devices within the pharmaceutical and life science sectors. The specialist will design, plan, coordinate, and oversee studies supporting product development and lifecycle management, specifically focusing on biocompatibility and toxicology. Key tasks include creating Biological Safety Evaluation Plans (BSEP) and Biological Risk Assessments, managing preclinical biocompatibility studies, and ensuring data quality, adherence to timelines, and budget compliance. A successful candidate will hold a degree in natural sciences (e.g., Biology, Biochemistry, Pharmacy) and possess initial experience in preclinical testing procedures (in vitro, in vivo, ex vivo) and medical device biocompatibility assessment. The position requires excellent written and verbal English skills, precise working methods, and strong time management capabilities, offering a chance to grow expertise in regulatory documentation for market authorization (IDE, BSER, IND, eCTD).