Melissa Hall
Former-FDA/Statera Regulatory Consulting/Medical Devices/Premarket Strategy/Submission preparation
- Role
- Founder and Principal Consultant at Statera Regulatory Consulting, Llc
- Location
- Annapolis, MD, US
- LinkedIn followers
- 500 followers
About Melissa Hall
I am a seasoned medical device regulatory expert with over 10 years of experience. The majority of my experience lies within the premarket space of the Food and Drug Administration (FDA). I have held various roles in the agency including lead reviewer, assistant director, consumer safety officer, and policy analyst. My review expertise ranges across all premarket submission types, with specific expertise in the orthopedic space. As a consumer safety officer I served as an industry educator of the premarket regulatory processes, and as a policy analyst, I served as a regulatory expert for the center addressing complex regulatory issues for all medical device types and ensuring laws, regulations, and guidances were applied consistently across the center. Now serving as a consultant, I continue in my passion to advancing public health by assisting the medical device community in their efforts to navigate the complex regulatory process and strategize the best path that aligns with their business goals. I have experience in developing regulatory strategies and submissions for a broad range of devices including SaMDs, hearing aids, orthopedics, dental, etc.
Experience
Founder and Principal Consultant
Statera Regulatory Consulting, Llc
Jan 2024 — Present · Annapolis, MD, US
Education
University of Maryland Baltimore County
Bachelor of Science, Biology
2003 — 2007
Broadneck High School
High School Diploma
1999 — 2003
New Jersey Institute of Technology (NJIT)
Master of Science, Biomedical Engineering
2008 — 2010
Skills
- Biomedical Engineering
- Medical Devices
- Biomechanics
- Biomaterials
- Fda
- Cell Biology
- Clinical Research
- Matlab
- Patents
- Physiology
- Patent Prosecution
- Patentability
- Intellectual Property
- Healthcare
- Biotechnology
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