Job Requisition NameSenior Biocompatibility Scientist
Job Requisition NoVN8489
Work Location NameUSA - Waltham
Worker BasisFull Time
Worker TypeEmployee
Contract TypePermanent
Applications Close DateDec 31, 2026
PurposeWe are seeking a Senior Biocompatibility Specialist to lead biological safety evaluations across our medical device portfolio. In this role, you will fill documentation gaps on legacy product families, 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. You'll also help standardize how the organization approaches biocompatibility by building SOPs, templates, and workflows that improve consistency and audit-readiness.
Key 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
QualificationRequired:
- 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 successfully 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 (
Preferred Skills:
- Certification and/or specialized training such as ABSA International Certified Biological Safety Professional (CBSP), AAMI Biological Evaluation Course, or other Notified Body / third party certificates: TUV SUD, LNE-GMED, NAMSA
