- Public Health, Public Policy and Non-Profit Sector
- Regulation of Medical Devices and Combination Products
- Premarket Medical Device Submissions (Pre-Subs, Submission Issue Requests, Requests for Designation, Breakthrough Device Designations, 510(k)s, Investigation Device Exemptions)
- Emergency Use Authorizations (EUAs)
- 4+ years regulatory consulting experience
Samantha brings a diverse background of public health knowledge to her role as Director of Regulatory Affairs at Greenleaf Health. Through her public health studies and prior experience, Samantha gained critical public health knowledge that has allowed her to effectively assist clients with developing communications and advocacy strategies, staying informed on evolving regulatory requirements, and providing strategic insight on critical regulatory challenges.
In her role at Greenleaf, Samantha conducts research projects for medical device clients to use in strategic planning, such as crafting regulatory landscape analysis on key topics based on FDA databases and guidance documents. Samantha provides strategic advice to clients regarding potential regulatory pathways for their devices and assists clients with their FDA submissions and correspondence. Samantha also reviews, drafts and files premarket FDA submissions for medical device clients including Pre-Submissions, Breakthrough Device Designations, Investigation Device Exemptions (IDEs), Requests for Designation (RFDs), 510(k)s and Emergency Use Authorizations (EUAs).
Samantha currently serves on the Board of the Xavier Young Professionals Network, a purpose-driven, collaborative community for Quality and Regulatory professionals in the life sciences industry.
Prior to joining Greenleaf, Samantha gained policy and advocacy experience at Management Sciences for Health (MSH). She also previously volunteered with Arts for Dementia, an organization in London, England that provides art and music therapy for individuals living with Dementia and Alzheimer’s disease.
Samantha earned a B.A. Psychology from Boston University and an M.P.H. from Boston University’s School of Public Health.