Artificial Intelligence (AI) as Medical Device MasterClass - EU edition

Nataliya Noreika, a seasoned professional with a distinguished career in Regulatory Affairs and Quality Assurance.

With over 14 years of hands-on experience navigating complex regulatory frameworks, she offers comprehensive expertise to ensure compliance with worldwide medical device regulations. Previously, she was Head of Quality and Regulatory at several medical device companies; she has successfully orchestrated the certification of Quality Management Systems (QMS), facilitated regulatory approvals across multiple jurisdictions, and optimised compliance practices to align with the latest industry regulations.

Armed with an MSc from the National University of Life and Environmental Sciences of Ukraine and a BSc from Munster Technological University in Ireland, she has been dedicated to ensuring product safety and global regulatory compliance. She is also PRINCE 2 certified in Project Management, a certified lead Quality Systems auditor, a member of the Regulatory Affairs Professional Society (RAPS). She holds the RAPS Regulatory Affairs Certificate (RAC) credential for Global Medical Devices, Drugs and Biologics. She has a proven track record in guiding products from concept to market, guaranteeing customer satisfaction worldwide.