Description: Medical device and diagnostics engineer with experience in FDA cleared and approved medical device development, EU medical device directive, quality assurance in medical device production, product labeling, advertising, and promotion. This expert’s regulatory affairs experience pertains to FDA regulated device market in the United States, Canadian and European notified bodies, and exporting to Asia. She also has experience with hospital and clinic purchasing, operating room and catheter lab sales and support. She is a Principal Investigator for NIH, FDA, and DoD funded SBIR/STTR grants and has participated in NIH I-Corps.

Location: San Francisco, CA