Karen Wu

Karen Wu, M.S., RAC, is an experienced professional in regulatory affairs with a robust background in managing regulatory compliance projects for medical devices across multiple regions. Currently serving as the Director of Regulatory Affairs at ClaroNav since August 2023, Karen previously held the role of Regulatory Affairs Manager/Consultant at Actalent, where responsibilities included developing regulatory strategies for medical device submissions. Prior roles include International Regulatory Affairs Manager at ZOLL Medical Corporation, where Karen supported global regulatory registration efforts, and Regulatory Affairs and Quality Complaints Manager at Cardinal Health, leading cross-functional regulatory projects. Early experience includes positions at Abbott and Zimmer, focusing on Canadian regulatory compliance and quality management. Educational qualifications include a Master of Science in Regulatory Science from The Johns Hopkins University and multiple certifications related to regulatory affairs and quality operations.