Director, Biocompatibility (Santa Clara)

Job ID: 31132139Posted: Posted 26 Days AgoStart Date: 2026-06-30Location: United States - California - Santa Clara, United States of AmericaTime Type: Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream ofEmployees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar yearAn excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degreeA 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 FortuneA 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 scientistsThe OpportunityThe Director, Biocompatibility is responsible for providing strategic leadership and scientific direction for the global biocompatibility and materials safety program supporting medical devices and combination products. This individual will lead teams of scientists and toxicologists to ensure compliance with international biocompatibility, extractables and leachables, and materials characterization standards, while driving innovation and operational excellence in biological safety evaluation. The Director will serve as the company’s subject matter expert and key liaison with regulatory agencies, internal stakeholders, and external partners on all matters related to biological evaluation and materials safety.This position will be located in Santa Clara, CA or Saint Paul, Minnesota.What You’ll Work OnStrategic Leadership: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.Team & Functional 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.Regulatory & Compliance Oversight: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.Technical Leadership: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.Cross-Functional Collaboration: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.Key Relationships:The position interacts directly with functional groups including R&D groups, Preclinical, Regulatory, Analytical Chemistry, and Quality groups in the Abbott various business Divisions and CROs.QualificationsBachelor's degree requiredPh.D. or M.S. required in Biology, Biomedical Engineering, Materials Science, Toxicology, or related discipline, preferably with a specialism relating to medical devicesMinimum of 12 years of relevant experience required in biocompatibility, toxicology, materials safety, or related within the medical device or combination productMinimum of 5 years of leadership experience, including managing scientific teams and cross-site functionsProven record of leading global biocompatibility or toxicology programs supporting regulatory submissions and product approvalsExpert in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993Strong understanding of extractables and leachables, chemical characterization, and toxicological risk assessment methodologiesExcellent scientific judgment and strategic thinkingExceptional communication, collaboration, and influencing skillsDemonstrated ability to lead in a global organizationRegulatory interaction experience (FDA, notified bodies, etc.) strongly preferredAPPLY NOWLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobalThe base pay for this position is $172,000.00 – $344,000.00In specific locations, the pay range may vary from the range posted.JOB FAMILY:Product DevelopmentDIVISION:MD Medical DevicesLOCATION:United States > Santa Clara : Building B - SCADDITIONAL LOCATIONS:United States > Minnesota> St. Paul > Woodridge : 177 East County Rd BWORK SHIFT:StandardTRAVEL:Yes, 20 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: is the Law link - Espanol: