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Biocompatibility Manager
Senior Manager – Biocompatibility
Location: UK-Based (Remote/Hybrid Working Available) Job Type: Permanent Travel: Approximately 25% across Europe and internationally
About the Role
We are seeking an experienced Senior Manager – Biocompatibility to join a leading global medical device organisation. This is an exciting opportunity to lead a team of specialists responsible for biological evaluations across a diverse portfolio of healthcare products, supporting both new product development and lifecycle management.
Working closely with R&D, Regulatory Affairs, Clinical Affairs, and Quality teams, you will play a key role in ensuring products meet global regulatory and biocompatibility requirements while driving scientific excellence and innovation.
Key Responsibilities
- Lead, mentor, and develop a team of biocompatibility specialists
- Manage priorities and resources across new product development and lifecycle management projects
- Provide technical leadership on biological evaluation strategies for medical devices
- Oversee biocompatibility testing programmes and biological evaluations in line with ISO 10993 requirements
- Support biological risk assessments, hazard analyses, and extractables & leachables evaluations
- Analyse, interpret, and present scientific data to support product development and regulatory submissions
- Drive continuous improvement initiatives across the biocompatibility function
- Ensure compliance with quality systems, regulatory requirements, and company standards
- Build strong relationships with cross-functional stakeholders across technical, regulatory, clinical, and commercial teams
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Requirements
About You
You will have:
- Significant industry experience within Medical Devices, Pharmaceuticals, or Biotechnology
- Extensive knowledge of biocompatibility assessments and biological evaluation requirements
- A strong understanding of ISO 10993 standards and global regulatory frameworks
- Experience supporting regulatory submissions across Europe and the United States
- Previous leadership experience managing and developing technical or scientific teams
- Excellent communication, stakeholder management, and collaboration skills
- A degree in Biomedical Engineering, Biology, Biochemistry, Microbiology, Toxicology, or a related scientific discipline – a Master's degree or PhD would be advantageous
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What’s on Offer
- Permanent position with a global healthcare organisation
- Flexible remote/hybrid working arrangements
- Opportunity to lead a highly specialised scientific team
- Exposure to innovative medical device development programmes
- International collaboration with global project teams
- Excellent opportunities for career progression and professional development
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