Robert Guzman is an attorney, licensed engineer, and regulatory affairs executive with more than 25 years of experience leading compliance, quality assurance, regulatory affairs, international trade, and corporate governance functions across the healthcare, pharmaceutical, biotechnology, and medical device sectors. He has held senior leadership positions with global healthcare organizations, including Getinge, C.R. Bard, and Chimerix, where he led regulatory strategy, healthcare compliance, quality systems, and international regulatory initiatives. Mr. Guzman worked closely with the U.S. Food and Drug Administration (FDA) in the development and implementation of the Unique Device Identification (UDI) regulation for medical devices, helping advance industry-wide device traceability and patient safety initiatives. While serving as Vice President of Compliance at Chimerix, he also led critical drug supply efforts during the Ebola crisis in Liberia in collaboration with the Bill & Melinda Gates Foundation, supporting the delivery of investigational therapies in response to the public health emergency.
Most recently, Robert served as Senior Director and Counsel at Getinge, advising business units across North America, Europe, Asia-Pacific, the Middle East, Africa, and Latin America on regulatory affairs, compliance, international trade, corporate transactions, and strategic growth initiatives. Earlier in his career, he served as Vice President, Quality Assurance & Compliance Officer at Chimerix and Senior Director, Regulatory Affairs at C.R. Bard.
Robert holds a Juris Doctor (J.D.) from the Pontifical Catholic University of Puerto Rico School of Law, a Master of Laws (LL.M.) in Corporate and Commercial Law from the University of London, a Master of Science in Life and Chemical Sciences from the University of Maryland, College Park, a Master of Business Administration (MBA) from the University of Massachusetts Lowell, and a Bachelor of Science in Industrial Engineering from the Polytechnic University of Puerto Rico.
As Chief Compliance & Regulatory Officer, Robert will lead the Company's compliance, regulatory, quality assurance, and governance functions, supporting Custom Health's continued growth within highly regulated healthcare and pharmacy markets across North America.
