Beaufort CRO Names Karin Hughes, Ph.D. as Senior Vice President, Regulatory and Quality
Industry Thought-Leader and Veteran Strategist to LeadFurther Expansion of Global Regulatory & Quality Services
NORFOLK, VA., July 14, 2020 —Beaufort, LLC, a leading provider of regulatory, clinical and quality solutions for in vitro diagnostic companies, recently announced Karin A. Hughes, Ph.D. as its new Senior Vice President, Regulatory and Quality.
Hughes joins Beaufort with 20+ years of industry experience in the in vitro diagnostic (IVD), biotech and life science industries. In her past management and leadership positions, Hughes guided the strategic planning and implementation of global regulatory, clinical, and quality management programs for projects spanning early development through product clearance and continued on-market expansion. Leveraging her strong technical background and product development expertise, Hughes enabled the progress of venture-capital funded, mid- and large-sized IVD companies by providing global regulatory strategic planning, aiding in submission preparation, clinical study design and execution, and offering on-market regulatory support, as well as quality management system development, implementation and oversight.
“The global regulatory, clinical and quality in vitro diagnostic landscape is rapidly evolving due to both new and imminent regulations, such as the EU IVDR and the US VALID ACT, as well as the increasing demand for high-quality, on-market in vitro diagnostic products related to the COVID-19 pandemic,” commented Clay F. Gill, President. “The addition of Karin’s leadership to the Beaufort team presents an even greater opportunity for us to provide innovative and comprehensive solutions that meet the needs of current and future clients.”
Since 2010, Hughes held the position of Vice President Regulatory & Clinical Strategy at Astute Medical, Inc., where she established and led the company’s regulatory, clinical, quality, compliance and ethics teams. She conducted a wide spectrum of clinical trials, and secured CE mark and US FDA clearance through FDA’s de novo classification pathway for the first-of-a-kind NephroCheck® Test System. Hughes provided regulatory support to Astute’s Pharma, Medical Device and licensing partners and led the company’s strategic planning to implement the EU In Vitro Diagnostics Regulation (IVDR).
Based in San Diego, California, Hughes is an active member of the Board of the Association of Medical Device Manufacturers. Hughes holds a bachelor’s degree in Chemistry from Hartwick College, and a Ph.D. in Chemistry from the University of Virginia.
About Beaufort CRO
Beaufort CRO is a global contract research organization (CRO) that provides in vitro diagnostic (IVD), medical device and biopharmaceutical companies with a full range of regulatory, clinical, and quality solutions. For over 15 years, Beaufort has earned a reputation for its client-oriented approach to research and demonstrated success in helping sponsors accelerate the development and market readiness of their medical innovations. Our depth of experience and proven track record of working closely with regulatory agencies globally means we apply the highest level of expertise across every step of the process from project inception through regulatory clearance. Learn more at BeaufortCRO.com.