|Diane C. Tiernan, MS, RAC|
Diane C. Tiernan has 25 years of experience in medical device regulatory affairs. Tiernan currently serves as a regulatory consultant to the medical device and combination product industries at DCT Ltd. Her role at DCT Ltd. includes providing regulatory guidance to clients with products in any phase of product development, including preparing and filing regulatory submissions and acting as a liaison between the client organization and regulatory authorities. Tiernan recently served as the regulatory affairs manager at Covidien BioSurgery, a medical device company based in Waltham, MA. Her responsibilities at Covidien BioSurgery included developing regulatory strategies and providing postmarket in support of global marketing and sales activities for surgical sealant products. Before joining Covidien BioSurgery, Tiernan was associated director of Regulatory Affairs at Alkermes, Cambridge, MA, a biotechnology company focused on injectable drug-delivery products. Prior to Alkermes, she held regulatory affairs positions with Bio-Reg Associates (Beltsville, MD), Synthes Spine (Paoli, PA), MedChem Products Inc. (Woburn, MA), CR Bard (Billerica, MA), and Symbion Inc. (Salt Lake City, UT). In those positions, she oversaw U.S. and European device regulatory filings, liaised with regulatory agencies, and monitored clinical trials.
Tiernan began her career as a certified audiologist, working extensively with cochlear implants. She received her BA in speech pathology from the University of Connecticut and her MS in audiology from Ithaca College. In addition to being a member of the Regulatory Affairs Professionals Society (RAPS), she is the former chair of the Boston chapter of RAPS. She has been a member of MD&DI’s Editorial Advisory Board since 2006.