MSc with 10+ years’ Experience in Quality System Regulations

Master’s Degree in Mechanical Engineering. In her 11.5 years as an official, Seema is famously known for being the first Investigator in the door to start the infamous Theranos case.

Worked as an FDA investigator and medical device specialist for over 10 years, conducting audits in the U.S. and internationally (Europe, China, India, Japan, Taiwan).

Engaged in training and supervising FDA investigators and served as a subject matter expert, mentor, and presenter for FDA’s National New Hire Training courses. Collaborated with industry and foreign regulators regarding FDA’s inspectional process.

She served as an Investigator for 15 years before leaving to start private consulting. She specializes in medical and invitro diagnostics devices, combination products, and pre-approvals.