Hilda F. Scharen-Guivel
Regulatory Advisor
Hilda is a former U.S. FDA director and 27-year Public Health Service veteran who helps life science and MedTech companies turn regulatory complexity into competitive advantage. She led national programs at the Department of Health and Human Services that advanced patient safety, streamlined FDA approval pathways, and promoted medical device innovation.
Today, Hilda serves as an independent director for Iradimed Corporation, a $90M manufacturer of non-magnetic MRI compatible devices, where she sits on the audit and compensation committees and advises on strategy, risk, and succession planning. She is also a trustee of St. Anthony’s Hospital and a member of the BayCare Medical Group Board, contributing to the governance of Florida’s $6 billion BayCare Health System.
Through her consulting practice, Hilda guides financial institutions and growth-stage companies on commercialization strategy, revenue enhancement opportunities, and optimized FDA pathways. She mentors entrepreneurs in the University of South Florida incubator and Stanford University’s School of Medicine M-TRAM program, sharing a global perspective that is strengthened by fluency in French and a broad professional network. At NeuroEM, Hilda combines board-level insight with deep regulatory expertise to optimize enterprise strategy, accelerate innovation, and unlock new market opportunities for cutting-edge neurotechnology.