Director, Regulatory Affairs
Under Emily’s leadership, EVERSANA’s regulatory affairs consulting team has a proven record of providing successful global regulatory affairs support to clients in the medical device, pharmaceutical, biologic, combination product and tissue industries.
With more than 10 years of experience in this field, she has authored and led: pre-IND meeting requests, INDs, Orphan Drug Designation, Fast Track and RMAT designation requests for pharma, biologic, and combination products in the ophthalmic, pain, imaging and more therapeutic areas; as well as regulatory assessments, pre-submissions, 510(k)s, Technical Files/Design Dossiers, STEDs, IDEs and PMAs in orthopedic, standalone software, ophthalmic, cardiovascular, in vitro diagnostics, anesthesiology, and more medical device therapeutic areas. She has effectively managed meetings with FDA, notified bodies, and similar regulatory agencies to achieve the desired results for her clients.
Emily holds a MS degree in Regulatory Affairs from George Washington University, and a BS degree in Biomedical Sciences from Colorado State University.