Megan Lamberti, MTM, CCRA
vice president, Clinical & regulatory affairs
Megan Lamberti has over 10 years of experience in clinical and regulatory affairs for the development and introduction of novel medical devices, in vitro diagnostics and pharmaceutical products. Megan holds a Master of Translational Medicine degree from the Bioengineering departments of University of California, San Francisco (UCSF) and UC Berkeley and a BS in Biomedical Engineering from Johns Hopkins University. She began her career working on low-cost medical devices for resource scarce healthcare environments. She then worked as an engineer for several start-up medical device companies and transitioned to managing clinical and regulatory affairs for a start-up company developing diagnostic and monitoring equipment for the intensive care unit. Since 2018, Ms. Lamberti has worked as a consultant specializing in clinical trial design and execution and regulatory affairs, including medical writing services. Megan has worked as a clinical research associate (CRA), monitor and project director on the CRO side of research, in industry, managing clinical affairs on behalf of her clients, and in academia as a clinical research coordinator, which has yielded her cross-functional skill sets in the conduct of clinical research.
Ms. Lamberti is a certified Clinical Research Associate (CRA) and has expertise with a wide variety of medical devices and in vitro diagnostic products across medical specialties. She has held roles in medical and technical writing, project management, manufacturing oversight, regulatory submission compilation, development of electronic data capture systems, clinical trial design/initiation/execution/closure, data management, regulatory strategy, non-clinical lab work, and clinical fieldwork. Megan has expertise in institutional review board (IRB), 510(k), PMA, orphan drug designation (ODD), investigational new drug (IND), CMS coverage request, investigational device exemption (IDE), breakthrough device, and technical file regulatory submissions and has worked on numerous non-significant risk (NSR), IDE and IND trials.
For more information, please see her LinkedIn profile.