Ashley Dynan brings 17+ years of pharmaceutical and medical device Quality Management Systems (QMS) and Regulatory Affairs experience to her role leading the ApiJect Regulatory Group. She focuses on developing and implementing regulatory strategies and processes for new and existing combination products and the ApiJect Platform.
Before joining ApiJect, Ashley most recently served as a regulatory and quality management expert for Network Partners, leading cross-functional teams in a variety of indications and product types in all stages of development for Class I, II, and III medical devices. She previously held regulatory positions with increasing responsibility with AlloSpice. Bellus Medical, Medtronic-Surgical Technologies, Stryker, Novartis Vaccines and Diagnostics, and Ioni Pharmaceuticals.
She is a certified quality auditor (ASQ), a certified lead auditor for MDSAP and ISP 13485:2016 (Oriel Stata Matrix), and a certified Regulatory Affairs Professional (RAPS) in Medical Devices and Pharmaceuticals. She earned her MPH in Healthcare Administration from Benedictine University and her BS in Medical Services from Concordia University Irvine.