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Senior Scientist - Biocompatibility

Real

Southampton

On-site

GBP 40,000 - 80,000

Full time

23 days ago

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An established industry player in medical devices is seeking a Senior Scientist specializing in Biocompatibility. This exciting role involves generating and maintaining Biological Evaluation Reports in compliance with EU MDR regulations. You will collaborate with diverse teams to ensure biocompatibility assessments meet industry standards and provide technical support across departments. This position offers a unique opportunity to lead initiatives in toxicological evaluations and regulatory compliance, making a significant impact on product safety and efficacy. If you are passionate about advancing medical technologies and thrive in a collaborative environment, this role is perfect for you.

BSc in a biological science or related discipline, MSc in Toxicology is a bonus.
Industrial experience in the medical device or pharmaceutical sector.

Compile biocompatibility assessments and maintain Biological Evaluation Reports.
Collaborate with cross-functional teams to support biocompatibility projects.

Biocompatibility assessments

Risk assessments

Biological Evaluation Reports (BERs)

Regulatory compliance

Toxicological safety assessments

BSc in Biological Science

MSc in Toxicology

ISO 10993

Our client is one of the world's leading manufacturers of medical devices with a presence in over 100 countries. They have a 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.

Responsibilities:

Compile and deliver biocompatibility assessments and biocompatibility evaluation plans
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
Collaborate with cross-functional teams to support projects requiring biocompatibility evaluation
Keep abreast of regulatory requirements including monitoring EU MDR, FDA and other agency regulations and international standards
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)
Ensure due process is followed under R&D Policies
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.

Qualifications:

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)
Direct experience working with ISO 10993
Success in leading change in particular for the implementation of ISO 10993 standards

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