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Biocompatibility Associate
2 months ago
Biocompatibility Associate – Global Medical Devices company – Yorkshire (hybrid working) - £competitive salary, bonus, pension, healthcare, 25 days holiday + BH
The Company
A market leading, global medical devices company focusing on multiple therapy areas. Their highlights include;
• Global medical devices company
• Distribute a range of devices from Class I-III across multiple therapy areas
• Award winning company
• Excellent training and development opportunities
• Idyllic location with plenty of onsite parking
The Role
Your responsibilities will include (but not limited to) the following;
- Creating, maintaining and updating biological evaluation plans (BEPs) and biological evaluation reports (BERs) for Class I to III devices
- Scheduling, managing and reviewing biocompatibility testing protocols and reports
- Scheduling, managing and reviewing extractables &/ leachables testing and reports, and TRAs, in accordance with ISO 10993
- Ensuring compliance with regulations
- Reviewing and providing input as necessary into technical files, clinical documentation, risk management and instructions for use with regards to biocompatibility
- Reviewing material safety datasheets and providing feedback and evaluation of such
- Assisting with any administration activities or product queries regarding biocompatibility actions
You
Ideally you will have experience in the following;
- Experience in biocompatibility within medical devices (2+ years)
- Experience of writing BEPs & BERs with (ideally) qualifications for BEP and BER writing per ISO 10993
- Experience of reviewing SDS, biocompatibility testing data, extractable and leachable data, toxicological risk assessments
- Working knowledge of the MDR, MDD and related ISO standards
- Experience with and writing of toxicological risk assessments (TRAs)
