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

FERCHAU GmbH Niederlassung Frankfurt

Frankfurt am Main, Hessen, Deutschland
Published Mar 31, 2026
Full-time
No information

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

English (Fluent)

Additional

  • Must be able to work precisely and manage strict project timelines for regulatory submissions.