Senior Scientist 1

As a Senior Scientist I - Biocompatibility, you 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. The role develops and executes biocompatibility strategies, collaborates with cross-functional teams, interprets biological safety data, and ensures compliance with global regulatory requirements including ISO 10993, 14971, 13485, FDA guidance, MDR (EU) 2017/745, and other international standards. The individual provides scientific leadership for new product development, clinical trials, sustaining engineering activities, regulatory submissions, and post-market support while ensuring patient safety and regulatory compliance.,

• 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 identify gaps, recommending contingency plans and strategies to mitigate these risks.
• 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/ 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 and 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.
• Influence project teams during product development and design change activities and present biological safety strategies and conclusions to leadership and regulatory.
• 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.
  
  Industrial experience in Medical Device, Pharmaceutical, or Biotechnology fields with expertise in biocompatibility, toxicology, and/or special process validation.
• A master's degree with extensive experience or PhD in a relevant engineering or scientific discipline may substitute for years of industry experience.
• Demonstrated experience supporting global regulatory submissions.
Technical Competencies
• 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 + 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.
• 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 Required:
• Proficient with MS Office (Word, Excel, Outlook, PowerPoint, SharePoint, OneDrive).
• 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 preferred.
• 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.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
  
  About Abbott Diabetes Care:
Bring your passion, ideas, and purpose to life in a company that can truly help you achieve your full potential. Known globally for the development of revolutionary technologies, Abbott Diabetes Care designs, develops, and manufactures glucose monitoring systems for use in both home and hospital settings. Abbott has been around for 135+ years, developing solutions for the world's health issues and creating a workplace that enables employees to live full lives. We have a Centre of Excellence in Witney for the manufacture of electrodes and biosensors used by patients and healthcare professionals for the day-to-day management of diabetes. The site has been instrumental in the research, development, and manufacture of the FreeStyle Libre 2, Free Style Libre 3 and the Libre Sense system.