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. Requirements 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 #J-18808-Ljbffr Jobtailor