Laurie Mendelson
Affiliate Assistant Professor, MS in Biomedical Regulatory Affairs (BRAMS) Program
Department of Pharmacy, Pharmacy Faculty, School Faculty
Email: lmendels@uw.edu
Courses taught
- PHARM 516: Introduction to Biomedical Regulatory Affairs
- PHARM 517: Introduction to Biomedical Regulatory Affairs
- PHARM 518: Product Testing, Evaluation & Post-Market Issues
Biography
Laurie Mendelson is an affiliate assistant professor in the UW Department of Pharmacy, where she co-teaches the courses for the Certificate in Biomedical Regulatory Affairs. She is the former director of the Division of Health Communication at FDA’s Center for Devices and Radiological Health. After leaving the FDA, Mendelson joined Bigfoot Biomedical, where she helped the company gain its first FDA 510(k) clearances (premarket submissions for regulatory approval) and implement post-market surveillance for a novel diabetes product. Currently, Mendelson consults with several medical device companies, providing guidance and hands-on support for pre- and post-market FDA regulatory compliance. She has a special interest in mentoring early-stage start-ups that are just beginning their regulatory journeys. Mendelson has a master’s degree in biomedical engineering from Case Western Reserve University.