The Senior Biocompatibility Specialist will work closely with Operations, Quality Assurance and Engineering to evaluate the biological safety of new products and assess manufacturing and design changes to existing medical products. The Senior Biocompatibility Specialist will work independently to perform risk assessments and develop test plans to fulfill biological safety requirements. This position will also ensure that the biological safety program is compliant to applicable global regulatory guidelines.
1. Responsible for independently drafting biocompatibility assessments and testing plans to comply with applicable biological evaluation standards and FDA guidance documents within a risk-based framework. 2. Develop and manage internal biological safety program to meet global requirements including chemical characterization, biological safety risk assessments and required test strategies/plans and documentation 3. Review biocompatibility test results to determine adequacy of data to meet requirements for the biological effects. Where applicable, utilize problem solving
skills and technical knowledge to troubleshoot unexpected results 4. Collaborate and clearly communicate with internal and external stakeholders to ensure appropriate planning, and execution of toxicological risk assessments and required testing with Contract Research Organizations 5. Utilize project management tools to help organize multiple requests and projects requiring biocompatibility evaluation/testing ensuring timely completion of testing to meet project schedules 6. Clearly communicate information (verbal
and/or written) to support regulatory submissions to global regulatory agencies. Where applicable, respond to additional information requests and serve as Subject Matter Expert in regulatory audits. 7. Collaborate with Supplier Quality, Engineering teams and with external vendors to procure material specifications and safety data sheets in order to assess safety of products 8. Participate in design and risk review meetings to assess products biological safety concerns, including documentation of biological safety assessments, test plans/reports 9. Maintain a working
knowledge of applicable external standards and perform gap analysis / impact assessment of external standards, regulatory requirements, and guidance’s associated with biological safety and related test methods 10. Function as lead auditor and/or subject matter expert for quality management system audits of laboratory service providers in accordance with applicable standard such as FDA, ISO 17025, ISO 13485, and international regulatory directives; 11. Represent Terumo Medical Corporation and the medical device industry through involvement in international standard committees such as AAMI, Advamed, ISO 12. Must maintain all training requirements for the position 13. Keep current on industry requirements for the biological safety of medical products.
Knowledge, Skills and Abilities (KSAs)