Sara McCutchan, Senior Regulatory Affairs Manager, has significant regulatory and quality assurance expertise in global marketing authorizations in diverse markets. Prior to joining Aristea, she played an integral role in the Regulatory Affairs function at Ardea Biosciences where she obtained and managed marketing authorizations in the US, EU, Latin America, Australia, and New Zealand. Sara has proven experience in managing projects and people across a range of providers and licensing partners. In addition to her Regulatory Affairs role at Ardea, Sara spent several years in Quality Assurance where she supported three successful FDA inspections, managed internal quality systems, and employee training.
Sara holds a BS in Cognitive Science from the University of California, San Diego and has a Regulatory Affairs Certification (RAC).
Current role
Director, Regulatory & Quality Assurance at Kyra Medical
Board Member & Director, Regulatory & Quality at KeriCure
Global Director, Regulatory, Quality, & Clinical Affairs at Invivoscribe
Director, Regulatory & Quality at Saladax Biomedical
Senior Director, Regulatory & Quality at NUVAIRA