Senior Biocompatibility Scientist: Lead Safety & Regulatory

BVI Medical; Waltham (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

BVI Medical is seeking a Senior Biocompatibility Specialist to lead biological safety evaluations across our medical device portfolio.

You will fill documentation gaps on legacy products, develop evaluation plans for new product development, assess biological safety impact for sustaining and post-market activities in accordance with ISO 10993-1, manage testing programs with contract labs, and serve as subject matter expert during FDA/notified body interactions.

Qualifications

• Bachelor's degree in Toxicology, Biomedical Engineering, Chemistry, Biology, or related field required.
• 5+ years of experience in biocompatibility evaluation within the medical device or combination product industry.
• Deep working knowledge of ISO 10993, FDA biocompatibility guidance, and toxicological risk assessment methodology.
• Experience authoring biological evaluation plans/reports that have been reviewed by FDA and/or EU notified bodies.
• Hands-on experience with extractables/leachables study design and toxicological interpretation of chemical characterization data.
• Familiarity with GLP-regulated testing environments and management of external testing labs.
• Strong technical writing skills; ability to translate complex toxicological data into clear risk-based conclusions for cross-functional and regulatory audiences.
• Excellent communication skills, both written and verbal.
• Ability to independently lead technical assessment(s), generating, and documenting plans and reports.
• Ability to manage multiple priorities simultaneously.
• Limited travel expected.

Responsibilities

• Lead retrospective biocompatibility gap assessments across legacy product families.
• Assess biological safety impact for sustaining and change management per ISO 10993-1.
• Develop and execute BEPs for new product development.
• Author and review BERs, TRAs, and material reports for submissions (510(k)/PMA/De Novo and CE).
• Manage biocompatibility testing programs with contract labs and ensure GLP compliance.
• Apply risk-based approaches to minimize redundant testing.
• Support post-market and complaint-driven biological safety assessments.
• Serve as SME during FDA/notified body interactions and audits.
• Develop and maintain SOPs, templates, and workflows for consistency and audit-readiness.

Education

Bachelor's degree in Toxicology, Biomedical Engineering, Chemistry, Biology, or related field

5+ years of experience in biocompatibility evaluation within the medical device or combination product industry

Deep working knowledge of ISO 10993, FDA biocompatibility guidance, and toxicological risk assessment methodology

Experience authoring biological evaluation plans/reports reviewed by FDA and/or EU notified bodies

Hands-on experience with extractables/leachables study design and toxicological interpretation

Familiarity with GLP-regulated testing environments and management of external testing labs

Strong technical writing skills; ability to translate toxicological data into clear risk-based conclusions

Excellent communication skills, both written and verbal

Ability to independently lead technical assessments and document plans/reports

Ability to manage multiple priorities simultaneously

Job description

BVI Medical is seeking a Senior Biocompatibility Specialist to lead biological safety evaluations across our medical device portfolio.

You will fill documentation gaps on legacy products, develop evaluation plans for new product development, assess biological safety impact for sustaining and post-market activities in accordance with ISO 10993-1, manage testing programs with contract labs, and serve as subject matter expert during FDA/notified body interactions.