Principal Toxicology 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 Reviewing and assessing of scientific and toxicological data Creating, maintaining and updating TRA's Performing literature searches and interpreting data Scheduling, managing and reviewing biocompatibility and toxicological testing protocols and reports Ensuring compliance with regulations and guidance 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 documents You Ideally you will have experience in the following; Experience in biocompatibility within medical devices (3+ years) Experience of writing BEPs & BERs with (ideally) qualifications for BEP and BER writing per ISO 10993 Experience with reviewing toxicological data and writing toxicological risk assessments Experience of reviewing material data sheets, biocompatibility testing data, extractable and leachable data, toxicological risk assessments, material literature Working knowledge of the MDR, MDD, FDA regulations, and related ISO standards Experience with current ISO 10993, MEDDEV and MDCG guidance, and ISO 14971.
What should you do next?
This Principal Toxicology 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.
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