Nada joined Experien Group (now Veranex) in 2017 after working 12 years at the FDA’s Center for Devices and Radiological Health (CDRH). Since 2010 she had been a CDRH senior science health advisor in the Center Director’s office. Nada combines her deep institutional knowledge with innovative approaches to help companies successfully communicate product information to the FDA throughout the total product life cycle. Leveraging her years of reviewer experience and broad FDA exposure, she develops actionable premarket strategies to guide programs through successful submission. She also orchestrates compliance activity. While at the FDA, Nada led postmarket investigations for OB-GYN devices, wrinkle fillers, tanning devices, breast implants, negative pressure wound therapy (NPWT) devices, and metal-on-metal hip implants, and she applies this knowledge to help companies effectively manage postmarket requirements.

At Veranex, Nada helps medical device and combination product manufacturers generate regulatory/clinical road maps for success. Building upon her strong engineering background, she helps companies devise and position product performance testing and/or clinical studies to achieve major milestones. Nada’s primary functions include:

  • Product information review and strategic regulatory/clinical assessment to devise long-term program and actionable milestones toward U.S. commercialization
  • Pre-submission support and FDA communication, including product positioning for device testing and clinical studies, including patient preference testing
  • U.S. regulatory submissions (e.g., IDEs, 510(k)s, PMAs, de novos, HUD/HDEs, 513(g)s, etc.)
  • Postmarket compliance advisory services
  • Veranex and client company representative at industry meetings and symposia, presenting as speaker or panelist to societies, universities, and public/private consortiums

Past companies and experience
Nada initiated her career at Biomat Sciences as an R&D engineer supporting dental products. She joined CDRH’s Office of Device Evaluation (ODE) in 2004 and led FDA review teams for first-of-kind (and sometimes controversial) devices, including a silicone gel-filled breast implant PMA, a drug-eluting neurovascular stent IDE, and two novel neurological stent HDEs for the treatment of atherosclerotic disease. As a Senior Science Health Advisor at CDRH, Nada led cross-Center and agency programs for the advancement of the FDA’s mission, including the Health of Women (HoW) program, the Network of Experts program, and the Patient Preference Initiative. She collaborated with the Center for Tobacco and the National Institutes of Health (NIH) to improve regulatory efficiency and to strengthen data collection, and she was the CDRH liaison and subject matter expert to the FDA’s Office of Women’s Health (OWH) and the Office of Minority Health (OMH).

Education
Nada holds a B.E. and an M.S. in biomedical materials science and engineering from Queen Mary College, University of London. She earned her MPH from Johns Hopkins Bloomberg School of Public Health. Nada is a Certified Quality Improvement Associate (CQIA) and a Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).

Back to Regulatory Affairs & Quality Management