Senior Scientist 1
On-siteWitney, England, United Kingdom
Job Summary
Lead biological safety evaluations for Class I–III medical devices by developing biocompatibility strategies, authoring Biological Evaluation Plans and Reports, and interpreting toxicological and extractables/leachables data. Design, oversee, and monitor in vitro and in vivo studies conducted by external laboratories while ensuring GLP compliance and managing technical deliverables. Serve as a technical reviewer for regulatory submissions, assess risks for material and process changes, and mentor junior scientists to drive best practices in ISO 10993 and 14971 compliance. Partner with cross-functional teams across R&D, quality, and regulatory affairs to support product lifecycle activities and global regulatory submissions.
Required Qualifications
- Industrial experience in Medical Device, Pharmaceutical, or Biotechnology fields
- Expertise in biocompatibility, toxicology, and/or special process validation
- A master's degree
- PhD in a relevant engineering or scientific discipline
- Extensive experience (substituting 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
- Knowledge of EU MDR requirements
- Experience with Material characterization
- Experience with Extractables & Leachables
- Experience with Toxicological risk assessment
- Experience with Biological evaluation reporting
- Experience with GLP testing oversight
- Strong scientific writing skills
- Strong data interpretation skills
- Proficiency with MS Office (Word, Excel, Outlook, PowerPoint, SharePoint, OneDrive)
- Strong verbal and written communication skills
- Ability to effectively communicate at multiple levels within the organization
- Strong technical writing skills
- 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
- Attention to detail
Desired Qualifications
- Board-certified toxicologist (DABT or equivalent)
- Experience interacting directly with FDA and notified bodies
- Knowledge of chemical characterization and analytical chemistry approaches
- Experience writing biological risk assessments for FDA and Notified Bodies
- Experience working in a broader enterprise/cross-division business unit model
- Experience working in a highly matrixed and geographically diverse business environment
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.