Regulatory affairs expert witnesses draw on careers in pharma, biotech, medical devices, and healthcare products to clarify compliance with FDA, EMA, and other regulatory frameworks. They evaluate submissions, labeling, quality systems, post-market surveillance, and risk management, and assess whether regulatory strategies, documentation, and decisions met applicable standards.
FDA Medical Device Regulation & Compliance Expert Witness
FDA Medical Device Regulation & Compliance Expert Witness
- Review Fee
- $400/hr
- Deposition Fee
- $500/hr
- Court Fee
- $500/hr
This FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of eight investigators as a Supervisory Consumer Safety Officer and then became a Compliance Officer, tasked with evaluating reports and lab analysis to determine compliance with regulation. The expert finished her FDA career as a Senior Case Review Expert, a role she held from 2008 until the end of 2015. In this position, she was responsible for reviewing and evaluating proposed judicial actions to determine if they were compliant with the requirements of the the Federal Food, Drug, and Cosmetics Act and other regulations. Currently, the expert runs her own consulting business.
Principal and Owner, A Regulatory Compliance Consultancy in CO
Master of Science (MS), University of Colorado
Littleton,
Colorado