B. Melina Cimler, Ph.D.

President - PandiaDx Consulting

Melina Cimler is a private consultant with PandiaDx Consulting, providing regulatory and compliance guidance for the development through commercial production and on-market support of medical device and diagnostic products. She has expertise in in vitro diagnostic product regulatory submissions, quality systems, organizational assessments, and strategic planning. She has over 21 years of experience in the FDA-regulated diagnostic industry leading regulatory, quality systems, clinical affairs, and research and product development. She has been very actively engaged in global government affairs, due diligence and alliance collaborations.

Dr. Cimler was most recently the Senior Vice President of Government Affairs at Beckman Coulter Inc.  Until October 2009, she was the Senior Vice President of Quality & Regulatory Affairs at Beckman Coulter where she was responsible for worldwide quality and regulatory strategies and activities.  She joined Beckman Coulter in December 2005 as Vice President, Regulatory Affairs.  She is an industry leader in Regulatory and Legislative Affairs, actively engaged in industry working groups advocating for the value of in vitro diagnostic testing and global access to novel and cost-effective diagnostic technologies.

Prior to joining Beckman Coulter, she was the Divisional Vice President of Quality, Regulatory & Clinical Affairs at Abbott Molecular, a Division of Abbott Laboratories.  Prior to her tenure at Abbott, she was Senior Director of Quality Assurance at Gen-Probe and led the quality systems effort to support regulatory approval and launch of the Procleix® HIV-1/HCV blood-screening assay.  She has held progressively responsible positions in R&D, Product Development and Quality Systems at CR Bard, Epitope and MicroProbe.  She received her Ph.D. in Pharmacology from the University of Washington in Seattle.