Manager Medical Regulatory Advisory Services
LINDA CHATWIN is Manager Medical Regulatory Advisory Services at UL LLC. 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. Her areas of regulatory expertise include developing international regulatory strategy; US FDA 510(k) and other regulatory submissions; classifications, listing and regulatory compliance issues – Health Canada; remediation efforts from audit findings; quality system construction and improvement; training to QSR, Risk management, RoHS and safety standards; risk management file construction and maintenance; gap assessments to various certification standards; 21 CFR Part 11 implementation; performing FDA Mock Audit and other outside auditing; managing FDA inspections; and developing, implementing and mitigating design control processes. Her legal expertise includes Coordinating corporate legal activities and General Counsel duties; review, negotiation and structure of agreements involving technology and licensing, as well as other commercial matters; providing legal and practical business advice, including medical device classification, marketing plans, real estate matters, employment, technology and risk management; and writing protocols, obtaining IRB approval and provided oversight in clinical trial for pharmaceutical product development.