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Abbott · 1 day ago

Director, Biocompatibility

Santa Clara, CA

Full-time

Onsite

Director/Executive

$197K/yr - $395K/yr

15+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Director of Biocompatibility is responsible for providing strategic leadership and scientific direction for the global biocompatibility and materials safety program supporting medical devices and combination products.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

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

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

Qualification

BiocompatibilityToxicologyMaterials SafetyRegulatory ComplianceLeadership ExperienceStrategic ThinkingCommunication SkillsCollaboration SkillsPh.D.M.S.ISO 10993ExtractablesLeachablesChemical CharacterizationRisk Assessment

Required

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