Linda M. Chatwin, Esq, RAC

North American Manager Medical Device Regulatory Services, UL, LLC, and Strategic Partner MasterControl Inc.

Linda M. Chatwin, Esq, RAC

North American Manager Medical Device Regulatory Services, UL, LLC, and Strategic Partner MasterControl Inc.

Biography

Ms. Chatwin has been involved with regulated medical products for over 30 years. She understands the global regulatory maze required to bring products to market, through years of watching regulations evolve and change. She holds a Regulatory Affairs Certification and is an attorney in the U.S.  She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. She has navigated many FDA inspections, and has negotiated favorable outcomes with FDA. Currently, she assists clients with regulatory issues and challenges, including implementation of UDI processes, performing mock audits, in-depth training on regulatory requirements and consulting on quality system development and improvement.