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Senior Biocompatibility Scientist
Job in
Waltham, Middlesex County, Massachusetts, 02254, USA
Listed on 2026-09-12
Listing for:
Physiol
Full Time
position Listed on 2026-09-12
Job specializations:
-
Healthcare
Medical Science
Job Description & How to Apply Below
- Conduct retrospective biocompatibility gap assessments across legacy product families, generating or compiling documentation to establish a comprehensive baseline of biological safety evidence
- Support sustaining and change management activities by providing strategic assessment of biological safety impact in accordance with ISO 10993-1
- Develop and execute biocompatibility evaluation plans (BEPs) for new product development initiatives in accordance with ISO 10993-1 and FDA guidance, aligned to device classification, contact type, and contact duration
- Author and review biological evaluation reports (BERs), toxicological risk assessments (TRAs), and material characterization reports supporting 510(k), PMA, De Novo, and international submissions (CE marking under MDR, etc.)
- Manage biocompatibility testing programs with contract testing laboratories, ensuring GLP compliance and scientifically sound study design
- Apply risk-based approaches to minimize redundant testing, leveraging existing data where scientifically justified
- Support post-market and complaint driven biological safety assessments
- Serve as biocompatibility subject matter expert during FDA/notified body interactions, audits, and responses to regulatory questions or deficiency letters
- Develop and maintain SOPs, templates, and standardized workflows for biocompatibility evaluations to improve consistency, efficiency, and audit-readiness across the organization
Position Requirements
10+ Years
work experience
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