Vesna Sevaljevic
Vesna holds a Master of Pharmacy and brings over 20 years of expertise in regulatory affairs, pharmacy, and marketing. She spent 12 years as a regulatory assessor at the Medicines and Medical Devices Agency of Serbia, specializing in EU medical device regulation. Her responsibilities included reviewing technical documentation, issuing product status opinions, advising on labeling and instructions for use, and classifying medical devices, IVDs, combination products, and software. Vesna also managed vigilance activities, including incident assessment, market surveillance, and adverse event reporting.
As a member of the CAMD working group, Vesna was involved in discussions on new legislations, both MDR and IVDR. Prior to joining Medcura, she led European Global Regulatory Affairs Solutions at Syneos Health, where she developed regulatory strategies, led interactions with notified bodies and health authorities, developed technical documentation, and authored regulatory submissions for a diverse range of medical devices, including drug-device combination products.