BD (Becton, Dickinson and Company) Nonclinical Biocompatibility Specialist in Covington, Georgia
Job Description SummaryThis position supports programs to address biocompatibility and nonclinical safety of medical devices and other relevant products produced by Becton Dickinson intended for registration and market by contributing to the development of evaluation programs and preparing and reviewing required documentation. The position will support products in the BD Interventional Segment (BD UCC), but may support other products and projects as required. This position will assist BD UCC with compliance to EU MDR.
1. Contribute to the design, execution and interpretation of preclinical safety, biocompatibility, analytical chemistry, and toxicological evaluation programs according to relevant regulatory requirements; including review of literature and assessment of compliance. Collaborate with CPDT SMEs, BD UCC project teams, business unit regulatory affairs staff, R&D/QA staff and outside suppliers as required to help define product testing requirements and coordinate with the project team to provide BD UCC deliverables.
2. Provide information relevant to testing to BD UCC EU MDR Project Management including device characteristics, clinical use and project/team milestones, as appropriate.
3. Assist and support the drafting and/or review of documents as required for regulatory registration/submission, regulatory compliance and support of product marketing. Also draft/review documents for internal change control processes in coordination with CPDT toxicologists as needed.
4. Support and provide biocompatibility-related process training as needed.
5. Maintain historical databases and perform searches of historical data, as needed.
6. Maintain knowledge of medical device regulations to assure compliance and conformance of BD CPDT programs for evaluation of medical device and other products.
Primary Work LocationUSA GA - Covington BMD
Work ShiftNA (United States of America)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.