Expert in Biocompatibility

To strengthen our team, we are looking for an additional

**Expert in Biocompatibility **| 100%**:
Ref. No. 6224
- Location:

- Burgdorf- | HybridHelp us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach.

**Your main tasks**:

- Define test strategies for the biological evaluation for individual products as well as product families. Coordinate the biocompatibility testing outsourced to the external laboratories or support the Ypsomed teams in these activities
- Summarize test results of the chemical characterization studies (leachables, extractables and their toxicological assessment) and biological tests that are carried out as part of the biological evaluation of the Ypsomed products
- Create biological evaluation reports according to ISO 10993 series for Europe, USA and other countries
- Ensure global compliance with legal requirements and compliance with standards and guidelines on the biological safety of products
- Perform biocompatibility assessment of changes on approved products
- Carry out gap analysis for updated standards of the ISO 10993 series and based on that perform gap analysis of the biocompatibility test reports in order to confirm the compliance with the updated standards or to initiate new biocompatibility testing for the products. Update the biological evaluation reports for the approved products as needed
- Support Product Management, Product Development, Marketing, Regulatory Affairs, Medical Affairs and Quality teams in questions related to biocompatibility. Support Regulatory Affairs teams in answering biocompatibility questions to regulatory authorities
- Maintain and develop current knowledge and expertise in existing regulations, global requirements and standards related to biological safety of medical devices
- It is highly welcome, if you are able to support project teams in the definition of the testing strategy for the in-use drug-device compatibility studies of some Ypsomed products

**Your profile**:

- At least MSs degree in Medicine, Biology, Chemistry, Biochemistry, Toxicology, Biomedical Engineering or any related discipline
- Fundamental understanding of the ISO 10993 series, other biocompatibility relevant standards and the MDR
- Extensive relevant work experience, at least 3 years, in the medical device and/or medical combination products field, biocompatibility and toxicology and experience with the above mentioned main tasks
- Work experience in the GMP-regulated setting of a medical device or pharmaceutical company
- Experience in toxicology (MAS, ERT and/or DABT) is an advantage.
- Good interpersonal and communication skills
- Fluent in English and German, both written and verbal