Director, Biocompatibility

RXinsider LTD.; Santa Clara (CA); On-site; USD 172,000 - 344,000; Full time

Job summary

Abbott is seeking a Director of Biocompatibility to lead global biological evaluation and materials safety for medical devices and combination products. The role directs teams of scientists and toxicologists, ensuring ISO 10993 compliance and regulatory readiness across geographies.

The position requires collaboration with R&D, Regulatory, and Manufacturing to drive safe, compliant product launches while engaging with regulators and external partners.

Qualifications

• Bachelor's degree in a relevant scientific field.
• Ph.D. or MS in Biology, Biomedical Engineering, Materials Science, Toxicology, or related discipline.
• 12+ years of experience in biocompatibility, toxicology, or materials safety within medical devices.
• 5+ years of leadership, managing scientific teams across sites.
• Proven track record leading programs supporting regulatory submissions.
• Strong expertise in US and global regulatory requirements for biocompatibility, ISO 10993.
• Experience with FDA and notified bodies interactions.
• Excellent scientific judgment and communication.

Responsibilities

• Provide strategic leadership for global biocompatibility and materials safety programs.
• Lead biocompatibility scientists across multiple sites with accountability.
• Ensure compliance with ISO 10993 and global regulatory guidance.
• Oversee evaluation plans, toxicology risk assessments, and testing strategies.
• Collaborate with R&D, Quality, Regulatory, and Manufacturing to ensure safety.
• Partner with cross-functional teams to enable safe product launches.

Skills

Biocompatibility

Toxicology

Regulatory strategy

Leadership

Global regulatory experience

Extractables & Leachables

ISO 10993

Scientific judgment

Communication

Cross-functional leadership

Education

Bachelor's degree

Ph.D. or MS in Biology, Biomedical Engineering, Materials Science, Toxicology, or related discipline

Job description

Abbott 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.

Working at Abbott

At 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 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

The Opportunity

The 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 On

Strategic 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.

Qualifications

• 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

Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is $172,000.00 – $344,000.00. In specific locations, the pay range may vary from the range posted.