Assistant Director, Division of Infection Control and Plastic Surgery Devices, Office of Surgical and Infection Control Devices, Center for Devices and Radiological Health
U.S. Food and Drug Administration
Silver Spring, MD
Julie Morabito is an Assistant Director with the Division of Plastic and Reconstructive Surgery in FDA’s Center for Devices and Radiological Health, where she oversees Plastic Surgery Skin and Wound Devices regulatory review activities. Previously, she was an Assistant Director overseeing the Medical Product Safety Network (MedSun) in CDRH’s Office of Clinical Evidence and Analysis, Division of Clinical Science and Quality, which facilitates CDRH’s engagement with the clinical community to advance medical device safety and quality signal detection and to improve patient and staff safety and medical device quality, based on real world data. Before joining MedSun, Julie was a premarket engineer reviewer in FDA’s Center for Tobacco Products, Office of Science. Julie earned her Bachelor’s degree and Ph.D. in Biomedical Engineering from Brown University, where she studied nerve regeneration and tissue engineering. Through a National Research Council Research Associateship Program, Julie engaged in stem cell tissue engineering as a postdoctoral researcher at the U.S. Naval Research Laboratory. Julie holds a Regulatory Affairs Certification (RAC US) and is ASQ Lean Six Sigma Green Belt Certified.
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Saturday, April 29, 2023
9:15 AM – 10:15 AM