Marie Rigley is a Regulatory Affairs Certified (RAC) professional with more than 15 years of medical device industry experience and a deep specialization in FDA regulatory strategy and market authorization. She serves as a strategic regulatory resource for portfolio companies and emerging MedTech entrepreneurs navigating the FDA regulatory landscape, helping translate early-stage innovation into compliant, submission-ready programs. A Senior Consultant through MedTech Impact Partners, she brings experience spanning all FDA submission types and Agency interactions, with particular strength in AI/NL-enabled devices, digital health, diagnostics, and combination products. Her regulatory expertise is further informed by a substantive background in Quality Management Systems and R&D, spanning design control, V&V, and risk management from feasibility through design transfer. She is recognized as a trusted regulatory authority by medical device companies seeking strategic, high-impact regulatory guidance.