Linda Chatwin

Linda
Chatwin

Senior Consultant, Quality and Regulatory Affairs


Linda Chatwin has over 30 years of experience with medical products. Through years of watching regulations evolve and change, she knows how to navigate the global regulatory maze and bring products to market. Linda has obtained approvals for a wide range of products and remains involved in changing requirements for medical devices worldwide. She has navigated many FDA inspections, and negotiated favorable outcomes with FDA. Currently, she assists clients with regulatory issues and challenges, including implementation of UDI processes, mock audits, in-depth training on regulatory requirements, and consulting on quality system development and improvement. She has also conducted numerous trainings and gap assessments for the new MDR compliance issues. Linda has worked with clients to assist them with regulatory compliance around the world, and lectures worldwide on the changing regulatory requirements. Previously, Linda held regulatory positions at Varian Medical Systems and Ultradent Products and has conducted business under organizations that she owned. She holds a Regulatory Affairs Certification and is a licensed attorney in the US.