For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
VP, Technical PC
Trisha is a versatile biomedical engineer and recognized subject matter expert. She has over 15 years of diverse experience in the development and regulation of medical products and implementation of scientific and regulatory policy. Notably, Trisha is experienced in regulatory review of devices that run the gamut of the benefit-risk spectrum as well as regulatory science research.
Before joining Parexel, Trisha held several positions within the FDA and multiple research and consultancy roles within the industry. Trisha has gained extensive experience in the engineering and clinical assessment of medical devices, including
breast implants, surgical mesh, sutures, and tissue markers. She has specialized knowledge in the regulation and policy considerations for combination products and accelerated approval pathways for medical devices in the United States.
Trisha was a lead reviewer on the full breadth of medical device premarket submissions (510(k)s, 513(g)s, IDEs, PMAs, De Novos, Breakthrough Device Q-Submissions) and has been recognized as a subject matter expert in nanotechnology, biocompatibility, and animal-derived materials.
Trisha holds a Ph.D. in Biomedical Engineering from Purdue University and a B.S. in Bioengineering with Minor in Mathematics, University of California, San Diego.