Senior Biocompatibility Scientist

Physiol; Waltham, Northern (MA, KY); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Physiol in the United States seeks a Biocompatibility Specialist to lead retrospective gap assessments and develop BEPs in line with ISO 10993-1 and FDA guidance. You will compile safety evidence across legacy products and coordinate with testing labs to ensure GLP-compliant study design.

This role involves authoring BERs, TRAs, and material reports for regulatory submissions (510(k), PMA, De Novo, CE MDR), guiding risk-based testing strategies, and supporting post-market activities and audits

Responsibilities

• 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

Job description

• 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