Due to expansion within the business we are looking for a new Toxicologist.
As our Toxicologist you will understand extractables and leachables and material characterisation. You will report to our Laboratory Manager and work with analytical chemists, partner CROs and clients.
You will have a good understanding of ISO 10993 series especially ISO 10998-18, MDD and FDA requirements and will be up to date with all regulatory requirements.
Your main responsibilities will be:
- Developing toxicity risk analyses for medical devices or pharma
- Toxicology risk assessment quality checks.
- Preparation of toxicological assessments.
- Provide high quality technical, scientific and regulatory advice based on the formulation of toxicology strategy.
- Collate and verify data sets to support toxicological risk assessments for customers.
- Delivery of technical reviews to support commercial projects.
You will have the following skills and qualifications:
- Strong academic background with, as a minimum, a relevant science-based degree (biology, biochemistry, chemistry, pharmacology etc.)
- Knowledge and understanding of regulatory affairs, especially European regulations governing product safety.
- Prior experience of, or evidence of a strong interest in product regulatory affairs, an understanding of chemistry, toxicology and exposure assessment as they relate to risk assessment.
- Knowledge of EU regulatory requirements (e.g. ISO 10998-18, MDD and FDA).
- Proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel.
- Ability to work independently with minimal supervision, and as part of a team.
- Desired qualities: independence, flexibility, communication, adaptability.