Director, Biocompatibility

Abbott

. Develop and execute the global biocompatibility strategy aligned with business and regulatory objectives.

Posted 4/26/2026full-timeCalifornia, Minnesota • 🇺🇸 United StatesLead💰 $172,000 - $344,000 per yearWebsite

About the role

Key responsibilities & impact

Develop and execute the global biocompatibility strategy aligned with business and regulatory objectives.
Provide scientific and regulatory leadership on biological safety and toxicological risk assessment for materials, manufacturing processes, and finished products.
Integrate biocompatibility considerations early in product design, development, and lifecycle management.
Lead and mentor teams of biocompatibility scientists across multiple sites.
Foster a culture of collaboration, accountability, and continuous improvement.
Oversee capacity planning, resource allocation, and performance management within the biocompatibility organization.
Ensure compliance with ISO 10993 and applicable global regulatory guidance.
Provide expert input for regulatory submissions (IDE, PMA, 510(k), CE, NMPA, etc.) and represent the function during audits and agency interactions.
Maintain strong awareness of evolving global biocompatibility and toxicology regulations and guide the organization in adapting accordingly.
Oversee biological evaluation plans, toxicological risk assessments, and testing strategies for medical devices and combination products.
Collaborate closely with R&D, Quality, Regulatory, and Manufacturing to ensure material and process changes are biologically safe.
Guide biological evaluation programs for complex devices and combination products.
Partner with materials science, chemistry, and analytical testing teams to establish integrated strategies for material characterization and safety.
Serve as a key advisor to product development teams to enable safe, compliant, and efficient product launches.
Engage with external experts and standards organizations to influence future regulatory and technical frameworks.

Requirements

What you’ll need

Bachelor's degree required
Ph.D. or M.S. required in Biology, Biomedical Engineering, Materials Science, Toxicology, or related discipline, preferably with a specialism relating to medical devices
Minimum of 12 years of relevant experience required in biocompatibility, toxicology, materials safety, or related within the medical device or combination product
Minimum of 5 years of leadership experience, including managing scientific teams and cross-site functions
Proven record of leading global biocompatibility or toxicology programs supporting regulatory submissions and product approvals
Expert in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993
Strong understanding of extractables and leachables, chemical characterization, and toxicological risk assessment methodologies
Excellent scientific judgment and strategic thinking
Exceptional communication, collaboration, and influencing skills
Demonstrated ability to lead in a global organization
Regulatory interaction experience (FDA, notified bodies, etc.) strongly preferred

Benefits

Comp & perks

Career development with an international company where you can grow the career you dream of
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

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Hard Skills & Tools

biocompatibilitytoxicologybiological safetyrisk assessmentISO 10993extractables and leachableschemical characterizationtoxicological risk assessment methodologiesregulatory submissionsbiological evaluation plans

Soft Skills

leadershipcollaborationaccountabilitycontinuous improvementstrategic thinkingcommunicationinfluencingscientific judgmentmentoringcapacity planning

Certifications

Ph.D.M.S.