Dennis Shay, Ph.D., Head of Regulatory

About > People > Dennis Shay, Ph.D., Head of Regulatory Affairs

Dennis Shay, Ph.D.

Head of Regulatory Affairs

Dennis has a successful track record of leading companies through difficult Quality and Regulatory challenges, using his science and engineering background to develop creative strategies to complex problems.


His past efforts include converting a contract manufacturer from zero to ISO 13485 in 6 months, submitting a Class III PMA for an FDA up-classification of defibrillation accessories, converting a portfolio of Class I and IIa EU technical documentation from MDD to MDR compliance, assisting in submission of complex multi-submission Class II infusion pump devices to FDA, leading efforts to implement a state-of-the-art Regulatory Information management System (RIMS), implementing a 21 CFR part 820 compliant validation program, and fully validating a state-of-the-art cleaning system for custom steel devices.


Dennis holds BS and PhD degrees in Materials Science and Engineering from Penn State University. He is Co-Chair of both the Boston Chapter of the Regulatory Affairs Professional Society (RAPS) and the New England Chapter of the American Society for Quality (ASQ), Biomedical Division.