BD (Becton, Dickinson and Company) Medical Lead EU MDR in Tempe, Arizona
Job Description Summary
Reporting to the Vice President, Medical Affairs BDPI, this role supports Medical Safety in the review of the Peripheral Intervention(PI) risk documentation, specifically EU MDR-related documents. This includes, but not limited to, Clinical Evaluation Reports (CER), Post-Market Clinical Follow up (PMCF) activities, as well as product Risk Management files required to have medical review and approval under the MDR regulation. Coordination and alignment on documentation reviews will occur between PI Medical Affairs management and the Medical Lead. Role can be 100% remote.
• Provides guidance and expertise for clinical evidence substantiation, in context of PMCF and EU MDR requirements.
• Works with the corporate medical affairs organization to assist with the review and approval of CER, PMCF, and Risk Management File documents (FMEA, RBA, V&V Testing, etc.)
• Evaluates the clinical context for CER by reviewing peer reviewed journal manuscripts, data sheets, white papers, web copy, user guides and other technical communication materials
• Ensures that accurate, high-quality documents are reviewed on schedule as per project timeline and workload demands
Primary Work LocationUSA AZ - Tempe BPV Building 4
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.