Our Team
Kristen Allen, BS, RAC
Founder and Principal Consultant
Kristen is a highly motivated regulatory affairs and quality professional with more than 15 years of experience in Class I instrument, and Class II/III implantable device submissions to the FDA and European regulatory bodies. She is familiar with FDA Guidance Documents, and navigates them with precision and creative insight. Her experience also includes management of post-market compliance, safety & recall decisions, establishment registrations, and Quality System requirements such as Design Control, CAPA and HCP contracting. Kristen is a graduate of the University of North Carolina at Wilmington (BS). Find her CV here.