JOB DESCRIPTION:The 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.
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
APPLY NOWLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
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.
JOB FAMILY:Product Development
DIVISION:MD Medical Devices
LOCATION:United States > Santa Clara : Building B - SC
ADDITIONAL LOCATIONS:United States > Minnesota> St. Paul > Woodridge : 177 East County Rd B
WORK SHIFT:Standard
TRAVEL:Yes, 20 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Keyboard use (greater or equal to 50% of the workday)
