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 related to biocompatibility and toxicology throughout the product development lifecycle. Day-to-day tasks include creating Biological Safety Evaluation Plans and Biological Risk Assessments, managing preclinical biocompatibility studies, and ensuring data quality, adherence to timelines, and budget compliance for all related activities. A key part of the role is supporting market authorization by preparing and updating regulatory documents (e.g., IDE, BSEP, BSER, IND, eCTD, IB, IMPD, toxicological assessment). Candidates should possess a natural science degree (Biology, Biochemistry, Pharmacy, or equivalent) and demonstrate very good written and spoken English skills, along with a precise working style and strong time management.