Director, Biocompatibility

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.

• 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