Senior Toxicology Professional
4 weeks ago
We are seeking an experienced Senior Toxicology Professional to join our client, a leading global medical devices company based in Yorkshire. This is an exciting opportunity to work with a reputable organization that values innovation and excellence.
Key Responsibilities:
- Create and maintain biological evaluation plans (BEPs) and biological evaluation reports (BERs) for Class I to III devices
- Review and assess scientific and toxicological data
- Develop and update toxicological risk assessments
- Perform literature searches and interpret data
- Schedule, manage, and review biocompatibility and toxicological testing protocols and reports
- Evaluate compliance with regulations and guidance
- Contribute to technical files, clinical documentation, risk management, and instructions for use related to biocompatibility
- Review material safety datasheets and provide feedback and evaluation
To be successful in this role, you will have a strong background in biocompatibility within medical devices (at least 3 years of experience) and relevant qualifications. Your skills and qualifications should include:
- Experience in writing BEPs & BERs with qualifications for BEP and BER writing per ISO 10993
- Knowledge of MDR, MDD, FDA regulations, and related ISO standards
- Understanding of current ISO 10993, MEDDEV, and MDCG guidance, as well as ISO 14971
- Excellent communication and analytical skills
This is a competitive salary opportunity (£competitive salary, bonus, pension, healthcare, and 25 days holiday + BH). Our client offers a dynamic work environment with opportunities for growth and development. If you are looking for a challenging role in a reputable organization, please apply or get in touch to discuss further.
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