Sr Biocompatibility Specialist – Temp
QM – Laboratory Operations
This is a request to engage an external resource on a temporary basis. Under this arrangement, Terumo will guide and direct the resource through the duration of the assignment. Please see notes for purpose, justification and responsibilities.
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.
**Auto req ID:**
+ Bachelor’s degree in Biology, Microbiology, Chemistry, Toxicology or Engineering with strong chemistry or biology background. Advanced degree is a plus.
+ Minimum 7 years experience in an FDA /ISO regulated environment performing biological safety assessments within a risk-based framework.
+ Must have prior experience independently developing biological safety assessments for inclusion with regulatory submissions
Affirmative Action/Equal Employment Opportunity Statement
It is the Company’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. In compliance with the Americans with Disabilities Act (ADA), if you have a disability and would like to request an accommodation with regard to the application and selection processes (for example, the online application process or interviews) or have any questions about our website accessibility, please call 732-302-4902 or e-mail us at Staffing@Terumomedical.com.