Regulatory affairs and quality professional with more than 15 years of experience supporting medical device companies across the full product lifecycle
CMC
Regulatory
Quality & Compliance
Kristen Allen is a regulatory affairs and quality professional with more than 15 years of experience supporting medical device companies across the full product lifecycle. She brings deep expertise in Class I instruments and Class II/III implantable device submissions, working extensively with the FDA and European regulatory authorities. Kristen is well versed in FDA Guidance Documents and is known for navigating complex regulatory expectations with both precision and creative insight. Her background includes managing post-market compliance activities, supporting safety and recall decisions, overseeing establishment registrations, and ensuring adherence to Quality System requirements, including Design Controls, CAPA, and healthcare professional contracting. Kristen combines technical rigor with practical problem solving to help organizations meet compliance objectives efficiently and effectively. She holds a Bachelor of Science degree from the University of North Carolina at Wilmington.
