Nada O. Hanafi, MSc, MPH
Senior Vice President – Regulatory Strategy at Veranex - Regulatory, Quality and Clinical Services
Co-Founder and Board Director – MedTech Color; medtechcolor.org
Nada is a results-oriented executive with over 20 years of experience advising CEOs and Founders in the MedTech and life-sciences industry. She possesses extensive experience with medical devices and combination products, specializing in software (AI/ML), plastic and reconstructive surgical innovations, neurology and aesthetics, hardware, regulated and wellness products.
Nada previously led cross-functional teams within FDA and NIH where she spearheaded high-impact projects in the areas of regulatory science and policy development, risk assessment, physician education, stakeholder engagement and collaboration with patient advocacy groups, and change management and can attract and retain talent by building a culture of inclusivity and diverse perspective to develop powerful solutions and strategies to advance health outcomes. She serves on the board of directors for Medtech Color and is also an advisor for startups (with a keen focus on women’s health), accelerators, and universities, including CLSI’s FAST program, MedTech Innovator, UC Berkeley's Master of Translational Medicine program, UCLA Biodesign, NIH and the Gates Foundation Innovation Equity Forum (IEF), as well as the AMA’s In Full Health initiative to advance equitable health innovation.
Nada is committed and leading the fight to bring equity, parity, and sanity to clinical research by advancing the MedTech Color Collaborative Community on Diversity and Inclusion in Medical Device Product Development and Clinical Research. Nada spent over 12.5 years at FDA’s Center for Devices and Radiological Health (CDRH) working on a range of products from breast implants to neurological devices and holding increasing positions of responsibility including as a Senior Science Health Advisor, serving as an expert consultant and senior advisor in the Center Director’s office and as such poses a deep institutional knowledge of FDA’s review processes. Nada was the Network Leader for Plastic and Reconstructive Surgery and Breast Implants and served as the CDRH Liaison and Subject Matter Expert to FDA’s Office of Women’s Health (OWH) and Office of Minority Health (OMH) to evaluate research proposals and intramural grant applications. Nada co-developed and lead the Health of Women (HoW) program at CDRH, with the goal to improve the health of women by; (1) Breaking the barriers that prevent the inclusion of women in clinical trials, (2) Improving the availability and consistency of sex-specific information for the safe and effective use of medical devices in women , and (3) advancing a targeted research roadmap.
As such, at Veranex, Nada overseas the regulatory team by supporting clients with both setting strategic direction, evidence pipeline and all aspects of design, development, commercial distribution of devices, and postmarket compliance to ensure products remain safe and effective while on the market.
Nada holds an MSc. in Biomaterials and a BEng in Biomedical Materials Science & 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) (2016).
