Melissa Hall, MS
principal regulatory consultant
Melissa Hall is a seasoned medical device regulatory expert with over 10 years experience. The majority of her experience lies within the premarket space of the Food and Drug Administration (FDA). She has held various roles in the agency including lead reviewer, assistant director, consumer safety officer, and policy analyst. Her review expertise ranges across all premarket submission types, with specific expertise in the orthopedic space. As a consumer safety officer she served as an industry educator of the premarket regulatory processes, and as a policy analyst, she served as a regulatory expert addressing complex regulatory issues and ensuring laws, regulations, and guidances were applied consistently across the center.
Now serving as a consultant, she continues her dedication to advancing public health by assisting the medical device community in their efforts to navigate the complex regulatory process and strategy that best aligns with their business goals. She has developed regulatory strategies and submissions for a broad range of devices including SaMDs, hearing aids, orthopedics, dental, etc. She is an active presenter on various premarket topics at various conferences put on by the Advanced Medical Technology Association (Advamed) and the Regulatory Affairs Professional Society (RAPS), as well as, recently co-authored a chapter in the upcoming new release of the RAPS Fundamentals of Medical Device Regulations book.
Melissa obtained her bachelor's degree in biological sciences at the University of Maryland Baltimore County and her master’s degree in biomedical engineering from the New Jersey Institute of Technology (NJIT), while also serving as an assistant volleyball coach to the Men’s and Women’s Division I Volleyball teams at NJIT. A student-athlete at heart, she now enjoys playing recreational ice hockey, while also serving as a team manager for her kids’ sports teams.
Melissa is the Founder and Principal Consultant of Statera Regulatory Consulting. For more information, please visit her LinkedIn Profile.