Business Wire09.11.20
Beaufort LLC, a provider of regulatory, clinical and quality solutions for in-vitro diagnostic companies, recently named Karin A. Hughes, Ph.D., as its new senior vice president, Regulatory and Quality.
Hughes joins Beaufort with more than 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 and 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 U.S. Food and Drug Administration (FDA) clearance through the FDA’s de novo classification pathway for the first-of-a-kind NephroCheck Test System. Hughes provided regulatory support to Astute’s pharmaceutical, 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, Calif., Hughes is an active member of the Board of the Association of Medical Device Manufacturers. Hughes earned a bachelor’s degree in chemistry from Hartwick College, and a Ph.D. in chemistry from the University of Virginia.
Hughes joins Beaufort with more than 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 and 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 U.S. Food and Drug Administration (FDA) clearance through the FDA’s de novo classification pathway for the first-of-a-kind NephroCheck Test System. Hughes provided regulatory support to Astute’s pharmaceutical, 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, Calif., Hughes is an active member of the Board of the Association of Medical Device Manufacturers. Hughes earned a bachelor’s degree in chemistry from Hartwick College, and a Ph.D. in chemistry from the University of Virginia.
