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)

What should you do next?

This Biocompatibility Associate role is one not to be missed; it encompasses the opportunity to work with a global medical devices client, who are going from strength to strength. To discuss this role further or to find out about other roles I’m currently working on, please get in touch or hit apply to submit your current CV.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

Carrot Recruitment acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.

If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we'll be more than happy to assist.