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Vice President, Regulatory and Clinical Affairs Irina Kulinets is the Vice President of Regulatory and Clinical Affairs at Anika Therapeutics. She joined the company in 2007 previously serving as Senior Director of Regulatory Affairs at BioSphere Medical in Rockland, MA. She has 17 years of experience in the medical device industry with large and small manufacturers including Boston Scientific, Johnson & Johnson/DePuy, and OmniGuide where she served in various Regulatory Affairs, Clinical Affairs, and Quality Assurance technical, management and senior management roles. From 2001 to 2004 she served as a Medical Regulatory Reviewer and Lead Medical Auditor for Notified Body, TUV America. In addition, she is certified by the FDA as a Third Party 510K reviewer. She holds MS and BS degrees in Mechanical Engineering from Belarus Polytechnic Academy and MS in Quality Assurance from California State University, Dominguez Hills. She is RAPS certified RAC, ASQ certified Six Sigma Black Belt, and ASQ Certified Quality Engineer. | 