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CytoSorbents Appoints Irina B. Kulinets, PhD, as Senior Vice President of Global Regulatory Affairs
Dr. Irina Kulinets, seasoned U.S. and international medical device regulatory expert, joins CytoSorbents' executive management team to lead FDA marketing
About this update from Cytosorbents Corporation
[{"type":"text","content":"Dr. Irina Kulinets, seasoned U.S. and international medical device regulatory expert, joins CytoSorbents' executive management team to lead FDA marketing approval of DrugSorb®-ATR and other global regulatory priorities\nPRINCETON, N.J., Jan. 17, 2023 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has appointed Irina B. Kulinets, Ph.D., as Senior Vice President of Global Regulatory Affairs. Dr. Kulinets brings more than 30 years of experience in regulatory affairs and clinical research of medical devices, biologics, and combination products in multiple therapeutic areas, including cardiovascular, neurovascular, oncology, orthopedics, biologic implants, and others. She will serve as a member of CytoSorbents' executive management team and will report to Vincent Capponi, President and Chief Operating Officer of CytoSorbents.\n\n \n \n \n \n \n \n\n \nDr. Irina Kulinets, seasoned U.S. and international medical device regulatory expert, joins CytoSorbents Dr. Kulinets was most recently the SVP of Regulatory Affairs, Clinical Research, and Quality at MicroVention, Inc., a division of Terumo Corporation and a global manufacturer of neuroendovascular medical devices. She has also worked for major U.S. and international life science corporations such as Johnson & Johnson, Boston Scientific, CynoSure, Anika Therapeutics, and BioSphere Medical. She has an extensive track record of international regulatory success with the approval/clearance of medical products in numerous therapeutic areas, including many Class II 510(k) and Class III Premarket Approval (PMA) medical devices. Dr. Kulinets has also provided executive strategic and operational leadership to help launch new products in the U.S., E.U., China, Japan, and many other Asian and Latin American markets.\nDr. Kulinets also has extensive experience as a regulator and worked for TUV America, Product Service - Medical Division and was appointed as a third-party FDA Inspector and 510(k) reviewer on behalf of the FDA to review, assess and approve new technologies.\nDr. Kulinets stated, \"I am excited to join CytoSorbents at such an important time in the Company's history as it nears th...