The Role
Your responsibilities will include (but not limited to) the following;
1. Creating, maintaining and updating biological evaluation plans (BEPs) and biological evaluation reports (BERs) for Class I to III devices
2. Scheduling, managing and reviewing biocompatibility testing protocols and reports
3. Scheduling, managing and reviewing extractables &/ leachables testing and reports, and TRAs, in accordance with ISO 10993
4. Ensuring compliance with regulations
5. Reviewing and providing input as necessary into technical files, clinical documentation, risk management and instructions for use with regards to biocompatibility
6. Reviewing material safety datasheets and providing feedback and evaluation of such
7. Assisting with any administration activities or product queries regarding biocompatibility actions
You
Ideally you will have experience in the following;
8. Experience in biocompatibility within medical devices (2+ years)
9. Experience of writing BEPs & BERs with (ideally) qualifications for BEP and BER writing per ISO 10993
10. Experience of reviewing SDS, biocompatibility testing data, extractable and leachable data, toxicological risk assessments
11. Working knowledge of the MDR, MDD and related ISO standards
12. Experience with and writing of toxicological risk assessments (TRAs)