Dr. Raji Pillai is a seasoned expert in developing and commercializing innovative medical devices and in vitro diagnostics under FDA and CLIA regulations. With 25+ years of industry experience in life sciences and molecular diagnostics, her background spans clinical, regulatory, medical and scientific affairs. As President of Medical Affairs Consulting Inc. which she founded 10+ years ago, Raji works with digital health, medical devices, genomics and in vitro diagnostics companies, ensuring compliance with applicable FDA Quality System Regulation requirements. Her work has led to clients securing FDA clearances and marketing authorizations.
Prior to establishing a consulting practice, Raji was VP Product Development & Clinical Affairs at Pathwork Diagnostics, where she led the development of the FDA-cleared, Medicare-reimbursed Tissue of Origin Test, an innovative oncology molecular diagnostic. She previously worked at Affymetrix, where she was responsible for managing strategic alliances and collaborations with key academic institutions and pharmaceutical companies worldwide, and diaDexus, where she established and managed the company’s microarray platform.
She received an A.B. in Biochemistry from Smith College, a Ph.D. in Biological Chemistry from UCLA and completed postdoctoral research in Biochemistry at the Stanford University School of Medicine.