Biocompatibility Specialist | Biocompatibility Specialist (m/w/d)
FERCHAU GmbH Niederlassung Frankfurt
Job Summary
As a Biocompatibility Specialist, you will take full responsibility for evaluating the biological safety and performance of medical devices throughout their entire lifecycle. Your daily activities will include designing, planning, and coordinating preclinical biocompatibility studies, as well as managing toxicology activities to support product development. You will be responsible for creating critical documentation such as Biological Safety Evaluation Plans (BSEP) and Biological Risk Assessments. Furthermore, you will play a key role in market authorization by preparing and updating regulatory documents (including IDE, BSER, and IND) to ensure compliance with international standards. This position is ideal for a detail-oriented scientist looking to bridge the gap between laboratory data and regulatory requirements. The role offers the security of a permanent contract, comprehensive pension benefits, and extensive professional development opportunities through an in-house academy, making it an excellent environment for career growth in the Life Sciences sector.
Required Skills
Education
Completed degree in natural sciences such as Biology, Biochemistry, Pharmacy, or a comparable field of study.
Experience
- Initial professional experience in biocompatibility evaluation for medical devices is desirable
- Experience in preclinical testing methods (in vitro, in vivo, ex vivo) is preferred
- Experience in managing biocompatibility activities and creating preclinical work packages
- Experience in supporting market authorization and regulatory filings (IDE, BSEP, BSER, IND, eCTD, IB, IMPD)
Languages
Additional
- Must be able to work precisely and manage strict project timelines for regulatory submissions.
More Jobs from FERCHAU GmbH Niederlassung Frankfurt
Commissioning Engineer | Inbetriebnehmer (m/w/d)
Apr 14, 2026
As a Commissioning Engineer at FERCHAU, you will be responsible for the global electrical commission...
Chemical Laboratory Technician - Quality Control and Development | Chemielaborant (m/w/d) Qualitätskontrolle und Entwicklung
Apr 14, 2026
This role involves working within a dynamic Life Science environment, focusing on the quality contro...
Chemical Laboratory Technician - Pharmaceuticals | Chemielaborant (m/w/d) Pharma
Apr 14, 2026
As a Chemical Laboratory Technician in the pharmaceutical sector, you will be responsible for conduc...