Director, Biocompatibility
Abbott
Director, Biocompatibility
Abbott
full-time
Posted on:
Location Type: Office
Location: Santa Clara • California, Minnesota • 🇺🇸 United States
Visit company websiteSalary
💰 $193,300 - $386,700 per year
Job Level
Lead
About the role
- 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
- 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 15+ years of relevant experience required in biocompatibility, toxicology, or materials safety within the medical device or combination product
- Minimum of 10 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
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
biocompatibilitytoxicologybiological safetyrisk assessmentISO 10993extractables and leachableschemical characterizationtoxicological risk assessment methodologiesregulatory submissionsproduct approvals
Soft skills
leadershipcollaborationaccountabilitycontinuous improvementstrategic thinkingcommunicationinfluencingscientific judgmentmentoringcapacity planning
Certifications
Ph.D.M.S.