Senior Biocompatibility Scientist

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

Purpose

We 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

Qualification

Required

• 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

Company

BVI® is refocusing the future of vision. As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries. We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus. Learn more at www.bvimedical.com