Director, Biocompatibility

JOB DESCRIPTION:

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. Youll 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 bachelors 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 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.

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 companys 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 Youll 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

• Bachelors 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.

Learn 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.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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Director