Samantha Eakes, MPH

Regulatory Affairs Practice

BACKGROUND

FOCUS AREAS

More than eight years of FDA regulatory consulting experience and a diverse background in public health, public policy, and the nonprofit sector.

Medical Device Submissions
Regulatory Research and Analysis

Samantha brings more than eight years of FDA regulatory consulting experience and a diverse background in public health, public policy, and the nonprofit sector to her position as Vice President of Regulatory Affairs at ELIQUENT Life Sciences.

Through her public health studies and prior experience, Samantha acquired critical knowledge and skills that allows her to effectively assist clients with developing regulatory strategies and premarket submissions, stay informed on evolving regulatory requirements, and provide strategic insight on critical regulatory challenges.

In her role on the Medical Devices and Combination Products team at ELIQUENT, Samantha advises clients regarding potential FDA regulatory pathways for their devices and assists clients with their FDA submissions and correspondence. She reviews, drafts, and files FDA premarket submissions for medical device clients, including: Pre-Submissions (Pre-Subs); Submission Issue Requests (SIRs); Requests for Designation (RFDs); Breakthrough Device Designation Requests; Investigational Device Exemptions (IDEs); 510(k) Premarket Notifications; De Novo Classification Requests (De Novo); Premarket Approval Applications (PMAs); and Emergency Use Authorizations (EUAs). Samantha also conducts research for medical device clients to use in strategic planning and analyzes the regulatory landscape using FDA databases, regulations, policies, and guidance documents.

Samantha has published articles and presented webinars on medical device-related topics such as cybersecurity, FDA’s least burdensome provisions, Emergency Use Authorizations and FDA’s eSTAR submission template.

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.

Stay informed as the regulatory landscape evolves. Subscribe to our blog to receive the latest updates on policy changes, FDA developments, and their impact on the life sciences industry.