TieTalent Southampton, England, United Kingdom
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About the role:
Our client is one of the world's leading manufacturers of medical devices with a presence in over 100 countries. They are offering a permanent position for a Senior Scientist - Biocompatibility, focusing on Biological Evaluation.
Responsibilities
1. Compile and deliver biocompatibility assessments and evaluation plans.
2. Generate and maintain Biological Evaluation Reports to meet EU MDR regulations.
3. Perform risk assessments and gap analysis of standards and regulations.
4. Collaborate with cross-functional teams on biocompatibility evaluations.
5. Stay updated on regulatory requirements including EU MDR, FDA, and international standards.
6. Assist in preparing toxicological safety assessments for materials, chemicals, and finished products.
7. Work within multidisciplinary teams including R&D, HS&E, Supply Chain, and RA/QA.
8. Ensure compliance with R&D policies and support strategy development for biological/toxicological evaluation.
9. Provide technical support and coaching to team members.
10. Offer consultancy on technical issues within R&D and other departments.
Qualifications
* BSc in Biological Sciences (e.g., Pharmacology, Biology, Physiology, Biochemistry) or related discipline.
* MSc in Toxicology or relevant work experience in toxicology is a bonus.
* Experience in the medical device or pharmaceutical industry preferred.
* Direct experience working with ISO 10993 standards.
* Proven success in implementing ISO 10993 standards and leading change.
For more information about the company, please visit their website.
Additional Details
* Location: Southampton, England
* Work Experience: Healthcare sector
* Languages: English
* Seniority Level: Mid-Senior level
* Employment Type: Full-time
* Job Function: Research, Analysis, IT
* Industries: Technology, Information, Internet
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