Debbie holds a Ph.D. in Biomedical Engineering from The Johns Hopkins University, School of Medicine where her dissertation focused the cellular pathways for axonal growth under the umbrella of spinal cord injury and regeneration. She also holds a Bachelor of Science in Biomedical Engineering from the University of Miami, Coral Gables, Florida.
Debbie has taught the FDA 510k and De Novo Process lectures as part of the Center for Bioengineering Innovation and Design (CBID) Master’s Program curricula at Johns Hopkins University. She has also served as a guest lecture to remotely teach the Overview of FDA Regulatory Process at the University of Maryland and Purdue University.
Debbie works at LivaNova as a Regulatory Affairs Senior Manager. Previously, she served as a lead reviewer and branch chief within the Center for Devices and Radiological Health at the US Food and Drug Administration (FDA). In this capacity, she oversaw U.S. market approvals of implantable devices for both the cardiovascular devices and neurological devices divisions within FDA. With more than 8 years of science research and extensive knowledge of US FDA and global regulations, Debbie thrives in learning about new technologies and applications that will help protect and promote public health.
- PHD Biomedical Engineering, Johns Hopkins University, School of Medicine
Regulatory Affairs Professional Society (RAPS)