Karen Bracke

Karen Bracke is a seasoned professional in quality assurance and regulatory affairs, currently serving as the IVD Device QA Lead Consultant at UCB since December 2022. With a strong focus on project management, Karen leads transversal PMO projects and is involved in the implementation of ISO 14155 requirements. Concurrently, Karen consults for BLUE ORQA BV, providing operational support in regulatory and quality affairs for the medical device and life sciences sectors. Prior experience includes roles as a QA/RA Consultant at Qualix Belgium, Medical Affairs & Marketing Manager at Flen Health, and various positions at St. Jude Medical and Advanced Bionics, where Karen contributed to product development and clinical research. Karen holds a Master’s degree in Biomedical Sciences from the University of Antwerp.