Carol Buchert
Director of Regulatory and Quality
Carol Buchert is the Director of Regulatory and Quality at MDC Associates, Inc. With over 25 years of experience in the MedTech industry, Carol has a proven track record of orchestrating the end-to-end development and delivery of a diverse range of regulated products and IVD and medical device projects. Her exceptional leadership and strategic vision have driven significant advancements in clinical diagnostics, in vitro diagnostics (IVDs), and medical devices.
Carol’s leadership career includes all aspects of quality, regulatory affairs, manufacturing, sales, and marketing. She excels in developing robust quality management systems and regulatory pathways that ensure compliance with stringent standards and regulatory requirements. Her expertise extends to managing IVD and medical device clinical studies, authoring a variety of regulatory submissions, conducting thorough audits, and providing comprehensive training to IVD and medical device companies as well as laboratory settings.
Prior to joining MDC Associates, Carol led U.S.-based regulatory and quality consulting teams at NAMSA, where she supported the North American, European, Japanese, and Chinese markets. Her strategic leadership at NAMSA involved providing adept guidance on regulatory strategies, submissions, and quality assurance, consistently exceeding project timelines, and delivering outstanding results for clients. She also co-founded and served as president of a successful MedTech company, focused on medical devices to purify white blood cells for bone marrow transplant and cell therapies, which was acquired in 2015.
