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Valynda Machen, CQA, RAC is a Principal Medical Research Manager at NAMSA. She has over 20 years of medical device experience in the areas of manufacturing, new product development, quality assurance and regulatory affairs, specializing in IVDs. In her current role at NAMSA, she provides regulatory services for clients in many areas including: peripheral vasculature, ophthalmology, IVD, regulatory compliance, quality systems, and UDI. Prior to NAMSA, she worked for Beckman Coulter where she managed pre- and post-market Regulatory Affairs activities for new and existing IVD products worldwide. Valynda holds a B.S. in Bacteriology from Iowa State University and has obtained certifications in quality auditing and regulatory affairs. She is a member of the Regulatory Affairs Professionals Society, Medical Alley, and MDIC.