Associate Director, Medical & Scientific Affairs
BD
Dona O’Neil is an Associate Director of Medical & Scientific Affairs at BD (Becton, Dickinson and Company), where she leads global medical affairs strategy in support of high‑risk medical device portfolios. In her current role, she serves as the EU MDR Medical Affairs Lead for BD’s Surgery business, overseeing clinical evidence, post‑market clinical follow‑up (PMCF), and real‑world evidence (RWE) strategies to sustain certification, protect global market access, and enable new product introductions.
Dona brings deep expertise in EU MDR implementation, clinical evaluation, PMCF, and the application of real‑world data to meet evolving regulatory expectations. She sits on BD’s Regulatory Strategy Center of Excellence (COE) team, where she advises on sufficient clinical evidence strategies, supporting enterprise‑level regulatory decision‑making and alignment across Medical Affairs and Regulatory Affairs.
She holds a Master of Public Health (MPH) from The George Washington University and is a SOCRA Certified Clinical Research Professional (CCRP), grounding her work in rigorous clinical research standards and regulatory science.
In addition to her industry role, Dona is an Adjunct Professor in Regulatory Affairs at Northeastern University, where she teaches FDA and EU medical device regulations. She is a frequent RAPS and MedTech conference speaker, panelist, and session chair, and a published thought leader on EU MDR and IVDR strategy.
Thursday, March 5, 2026
9:00 AM - 10:00 AM East Coast USA Time