Senior Scientist, Biocompatibility (Biological Evaluation)

Senior Scientist, Biocompatibility (Biological Evaluation)

CooperVision

Chandlers Ford, United Kingdom

Job summary – What to expect:

We have an exciting permanent opportunity for a Senior Scientist – Biocompatibility with a particular focus on Biological Evaluation. In this role, you will be responsible for generating, maintaining, and updating Biological Evaluation Reports (BERs) per EU MDR requirements. The role focusses on the toxicological and biocompatibility evaluation of products and technologies required for product approvals and the establishment of patient safety of medical devices in accordance with applicable global regulatory guidelines.

Additionally, the senior scientist will provide support to enable the delivery of toxicological risk assessments for different projects, process change assessments, material quality assessments including material supplier contamination, innovation projects and support to regulatory projects.

Key responsibilities include:

• Compile and deliver biocompatibility assessments and biocompatibility evaluation plans and reports in compliance with applicable biological evaluation standards and guidance documents.
• Generation and maintenance of Biological Evaluation Reports to meet EU MDR regulations.
• Perform and assist with risk assessments and gap analysis of external standards, regulatory requirements, and guidance documents associated with biological safety evaluation.
• Collaborate with cross-functional teams to support projects requiring biocompatibility evaluation and ensure timely completion to meet established deadlines.
• Keep abreast of regulatory requirements including monitoring EU MDR, FDA and other agency regulations and international standards with respect to biological evaluation.
• Prepare or collaborate in the preparation of toxicological safety assessments including materials, chemicals, technologies and processes or finished products.
• Work within multi-disciplinary teams (notably R&D, HS&E, Import/Export, Supply Chain and RA/QA) on a variety of activities as required by the business.
• Ensure due process is followed under R&D Policies and Framework.
• Support the creation and development of the strategy for biological/toxicological evaluation (including testing requirements) for materials and finished products.
• Provide technical support and coaching for members of R&D, regulatory or any other relevant department.
• Provide consultancy on technical issues both within R&D and other stakeholders.

About you:

We are looking for someone who is a strong team player with good stakeholder engagement skills who can bring with them the following experience:

• Either a BSc in a biological science (Pharmacology, Biology, Physiology, Biochemistry or similar) or related discipline (MSc in Toxicology or any work-related experience in toxicology a bonus)
• Industrial experience within the chemical area (Medical device/pharmaceutical preferred) depending on degree level
• Direct experience working with ISO 10993 is essential.
• Demonstrated success in leading change in particular for the implementation of ISO 10993 standards series is essential.
• Working knowledge of domestic and international regulations and standards that affect Class II and III medical device compliance is essential.

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