Senior Biocompatibility Manager

SRG; Greater London; Hybrid; GBP 92,000 - 110,000; Full time

Benefits offered by this job

Flexible remote working

International travel opportunities

Career development

Job summary

SRG is seeking an experienced Senior Manager of Biocompatibility to lead a specialist team delivering biological evaluations for a diverse medical device portfolio. You will align biocompatibility programs with ISO 10993 standards and global regulatory expectations, guiding strategies across R&D, Regulatory, Clinical, and Quality functions.

You will manage resources for development and lifecycle projects, drive improvements, and ensure compliance with global regulations while fostering

Qualifications

• Extensive biocompatibility expertise across devices/pharma/biotech.
• Proven leadership of scientific teams in a regulated environment.
• Experience supporting regulatory submissions in Europe and the US.

Responsibilities

• Provide technical leadership for biological evaluations under ISO 10993.
• Lead and mentor a team of biocompatibility specialists.
• Oversee biocompatibility testing programmes and biological evaluations.
• Collaborate with R&D, Regulatory Affairs, Clinical Affairs and QA.
• Ensure integration of biocompatibility activities into development plans/timelines.
• Drive continuous improvement in biocompatibility processes and data handling.
• Support risk assessments and hazard analyses related to biocompatibility.
• Present scientific data (e.g., extractables/leachables) to stakeholders.
• Ensure compliance with quality systems and regulatory requirements.
• Foster cross-functional collaboration across global project teams.

Skills

Biocompatibility leadership

Regulatory submissions

ISO 10993 knowledge

Stakeholder management

Team leadership

Education

Master's degree or PhD in a related field

Biomedical/biological/Biochemistry degree

Job description

Location: UK-Based (Remote/Hybrid Working Available)

Travel: Approximately 25% Travel Across Europe and Internationally

Salary + Benefits: 92-110K – 17.5% annual bonus

A leading global medical device organisation is seeking an experienced Senior Manager – Biocompatibility to lead a team of specialists responsible for delivering biological evaluations across a diverse portfolio of healthcare products.

This is a high-impact leadership position supporting both new product development and lifecycle management activities, working at the intersection of R&D, Regulatory Affairs, Clinical Affairs and Quality teams to ensure products meet global regulatory and biocompatibility requirements.

The Role

As Senior Manager – Biocompatibility, you will provide technical leadership and strategic direction for biological evaluations, ensuring compliance with ISO 10993 standards and global regulatory expectations. You will lead a team of experts, drive continuous improvement initiatives and work closely with cross-functional stakeholders to support innovation and product development programmes.

Key Responsibilities

• Lead, mentor and develop a team of biocompatibility specialists.
• Manage resources and priorities across new product development, research and lifecycle management projects.
• Provide expert guidance on biological evaluation strategies for medical devices.
• Work closely with project teams to ensure biocompatibility activities are integrated into development plans and timelines.
• Oversee biocompatibility testing programmes and biological evaluations.
• Support biological risk assessments and hazard analysis activities.
• Analyse, interpret and present scientific data, including extractables and leachables assessments.
• Drive continuous improvement initiatives across the biocompatibility function.
• Ensure compliance with quality systems, regulatory requirements and company objectives.
• Foster strong collaboration between technical, regulatory, clinical and commercial stakeholders.

About You

We're looking for an experienced scientific leader with:

• Significant industrial experience within Medical Devices, Pharmaceuticals or Biotechnology.
• Extensive knowledge of biocompatibility assessments and biological evaluation requirements.
• Experience supporting regulatory submissions across Europe and the United States.
• Strong understanding of ISO 10993 standards and global regulatory frameworks.
• Experience leading technical teams and developing scientific talent.
• Excellent stakeholder management and cross-functional 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.

What's on Offer

• Opportunity to lead a highly specialised scientific team within a global healthcare organisation.
• Exposure to innovative product development programmes and cutting-edge technologies.
• Flexible remote/hybrid working arrangements.
• International collaboration across global project teams.
• Career development within a growing and science-led business.

This is an excellent opportunity for a proven biocompatibility professional looking to combine technical expertise, people leadership and strategic influence within a global medical device environment.