Senior Scientist 1 in Witney

Senior Scientist I - Biocompatibility

Role: Serve as a technical subject matter expert responsible for the biological safety evaluation of medical devices, materials, manufacturing processes, and design changes throughout the product lifecycle.

Lead biocompatibility strategies, collaborate with cross functional teams, interpret biological safety data, and ensure compliance with global regulatory requirements including ISO 10993, 14971, 13485, FDA guidance, MDR (EU) 2017/745, and other international standards.

Provide scientific leadership for new product development, clinical trials, sustaining engineering activities, regulatory submissions, and post market support.

Key Responsibilities

• Lead biological safety assessments for Class I-III medical devices.
• Develop and justify biocompatibility strategies aligned with ISO 10993 requirements.
• Author and approve Biological Evaluation Plans (BEPs), Biological Evaluation Reports (BERs), toxicological risk assessments, and regulatory summaries.
• Evaluate material, supplier, process, and formulation changes for biological safety impact and recommend contingency plans and mitigation strategies.
• Serve as a technical reviewer for biocompatibility documentation and regulatory submissions to conduct biological hazard identification and risk assessments.
• Interpret biocompatibility, toxicology, extractables/leachables, and chemistry characterization data.
• Determine in vitro and in vivo testing requirements versus risk justification based approaches to support product lifecycle risk management activities in accordance with ISO 10993, 14971 and 13485.
• Design, oversee, and monitor biocompatibility studies (chemical, in vitro/in vivo testing) conducted by external laboratories.
• Review protocols, ensure GLP compliance, and assess scientific integrity of study reports.
• Manage external testing labs on timelines, budgets, and technical deliverables.
• Partner with R&D, Materials Science, Toxicology, Regulatory Affairs, Clinical Affairs, Quality, Manufacturing and Post Market to influence project teams during product development and design change activities.
• Present biological safety strategies and conclusions to leadership and regulatory bodies.
• Monitor global regulatory and industry trends impacting biological safety assessments and support development and improvement of internal procedures, templates, and standards gap assessments.
• Mentor junior scientists and engineers and drive best practices in biological evaluation and regulatory compliance.

Qualifications

• Industrial experience in Medical Device, Pharmaceutical or Biotechnology fields with expertise in biocompatibility, toxicology and/or special process validation.
• Master's degree with extensive experience or Ph D in a relevant engineering or scientific discipline may substitute for years of industry experience.
• Demonstrated experience supporting global regulatory submissions.
• Expert knowledge of ISO 10993 series.
• Understanding of ISO 14971 risk management principles.
• Knowledge of FDA biocompatibility guidance and EU MDR requirements.
• Experience with material characterization, extractables & leachables, toxicological risk assessment, biological evaluation reporting and GLP testing oversight.
• Strong scientific writing and data interpretation skills.
• Preferred
• Board certified toxicologist (DABT or equivalent).
• Experience interacting directly with FDA and notified bodies.
• Knowledge of chemical characterization and analytical chemistry approaches.
• Experience working in a broader enterprise/cross division business unit model.
• Leadership Expectations
• Functions as a recognized biocompatibility SME.
• Independently leads strategic projects with minimal supervision.
• Guides cross functional decisions related to biological safety.
• Mentors junior staff and develops organizational capability.
• Influences technical and business decisions through scientific expertise.

Skills and Abilities

• Proficient with MS Office (Word, Excel, Outlook, Power Point, Share Point, One Drive).
• Strong verbal and written communication skills, with the ability to effectively communicate at multiple levels within the organization.
• Strong technical writing skills, with experience in writing biological risk assessments for FDA and Notified Bodies.
• Ability to work within a team and as an individual contributor in a fast paced, changing environment.
• Ability to prioritize, complete deliverables in a timely manner, and meet deadlines.
• Strong organizational and follow up skills, with attention to detail.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Additional Information

Work shift: Standard. Travel: Yes, 5% of the time. Medical surveillance: Not applicable.

Equal Opportunity Employer

Abbott welcomes and encourages diversity in our workforce.