Caroline Byrd is VP of Regulatory, Quality, and Clinical at Nextern. A program management and business process improvement leader grounded in lean product lifecycle management, she drives cross-functional quality and regulatory transformation across product development, manufacturing, and operations. Her experience includes translating major regulatory changes—such as EU medical device requirements—into practical systems and processes, and leading global, cross-functional teams through organizational change. Caroline’s specialties include EU MDR, medical device quality systems, design controls, risk management, validation and verification, and manufacturing/operations.