Overview
This is a fantasy opportunity for a Biocompatibility Associate to join a Global Medical Device company based in North Yorkshire. You will be responsible for creating, maintaining and updating biological evaluation plans, biological evaluation reports, scheduling, managing and reviewing biocompatibility testing protocols and reports in accordance with ISO 10993.
Responsibilities:
- 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 in accordance with ISO 10993, and incorporating such into BEPs and BERs as necessary.
- Scheduling, managing and reviewing extractables & leachables testing and reports, and TRAs, in accordance with ISO 10993, and incorporating such into BEPs and BERs as necessary.
- Ensuring compliance with regulations and guidance (ISO 13485, ISO 14791, ISO 10993, MDR, MDCG, and other EU/UK and FDA guidance documents) and applicable SOPs
- 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
- Key biocompatibility lead on new projects and device change projects controlled by CCRs
- Responsible for creating, updating, maintaining and ensuring compliance with internal biocompatibility SOP in accordance with ISO 10993
- Input into regulatory submissions for Notified Body, Approved Body, US FDA, ROW competent authority, review and approval, as applicable.
- Liaise with cross functional teams and senior management and provide guidance regarding biocompatibility actions
- Assist in the preparation for annual QMS audits.
- Supporting in regular internal and external audits.
- Raise and/or complete actions as part of change control process.
- Assisting with any administration activities or product queries regarding biocompatibility actions
Knowledge & Qualifications:
Essential:
- Degree or equivalent certification in science related, medical, or engineering discipline.
- Experience within the medical devices sector (ideally 3 or more years experience)
- Experience of writing BEPs & BERs
- Suitable qualifications for BEP and BER writing per ISO 10993
- Experience of reviewing SDS, biocompatibility testing data, extractable and leachable data, TRAs
- Working knowledge of the MDR, MDD and related ISO standards
- Experience in the compilation of BEP & BERs for EU UK USA and ROW markets
- Experience with current ISO 10993, MEDDEV and MDCG guidances, and ISO 14971.
Desirable:
- Experience of EU MDR submissions and approval
- Experience of assisting with/conducting/managing Internal & External audits.
- Experience with and writing of toxicological risk assessments (TRAs)
Skills/Competencies:
- Capable of working in a team and independently.
- Problem Solver
- Able to project manage multiple tasks
- Understanding of manufacturing processes
- Good communication skills
- Organised working style
- Eye for detail
- High level of computer literacy
- Competent in writing BEP and BERs
- Competent in reviewing and interpreting biocompatibility testing data and literature
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.
Check us out on our website and LinkedIn for more roles.
We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU
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Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.
Check us out on our website and LinkedIn for more roles.
We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU
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Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.
Check us out on our website and LinkedIn for more roles.
We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU