Biocompatibility Specialist | Biocompatibility Specialist (m/w/d)
FERCHAU GmbH Niederlassung Frankfurt
Job Summary
As a Biocompatibility Specialist, you will play a critical role in ensuring the biological safety and performance of medical devices throughout their entire lifecycle. Your daily responsibilities include designing, planning, and coordinating toxicological activities and preclinical studies to support product development. You will be responsible for creating essential regulatory documentation, such as Biological Safety Evaluation Plans (BSEP) and Biological Risk Assessments, while managing preclinical work packages to ensure data quality and budget compliance. This role offers the opportunity to support international market approvals by preparing documents like IDE, IND, and eCTD. Working for a renowned service provider like FERCHAU in the Life Science sector, you will benefit from a permanent employment contract, structured professional development through an in-house academy, and a comprehensive benefits package including pension schemes and performance bonuses. It is an ideal position for a detail-oriented scientist looking to bridge the gap between laboratory data and regulatory compliance.
Required Skills
Education
University degree in Natural Sciences such as Biology, Biochemistry, Pharmacy, or a comparable field of study.
Experience
- Professional experience in biocompatibility assessment and biological safety of medical devices is desirable
- Experience in coordinating and monitoring preclinical testing activities (in vitro, in vivo, ex vivo)
- Experience in creating Biological Safety Evaluation Plans and Risk Assessments
- Background in supporting market authorization and regulatory documentation for medical products
Languages
Additional
- Permanent work contract; precise working style and strong time management skills required.
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