Her work as an executive and consultant resulted in defining, developing and implementing worldwide regulatory strategies, clinical strategies and quality initiatives to support corporate vision, mission and business objectives handling domestic and international medical device, pharmaceutical and biologic regulatory filings and product registrations. She was involved in designs and execution of all phases of pre-approval clinical trials and field evaluation (post-marketing) clinical studies, as well as in developing, implementation and maintenance of effective and compliant state-of-the-art quality systems.
Dr. Kulinets is a lecturer and the faculty director of the Master’s in Regulatory Affairs for Drugs, Biologics, and Medical Devices degree program at Northeastern University. She holds RAC (RAPS) certification and is also FDA Accredited Person Inspector, Certified Third Party FDA 510K Reviewer, Notified Body Design Dossier Reviewer, Lead Notified Body Medical Auditor, ASQ Certified Six Sigma Black Belt, ASQ Certified Quality Engineer (CQE), and Certified ISO 13485:2003/CMDR Lead Assessor. Dr. Kulinets is a member of the Regulatory Affairs Professional Society and the Association of Clinical Research Professionals, a senior member of the American Society of Quality, and a council member of the Life Science Division at Gerson Lehrman Group.