RDML (Ret.) Boyd Drove Many of the US Agency’s MedTech Regulatory and Quality Initiatives
Orlando, FL – RDML (Ret.) Sean Boyd, a 31-year veteran of the US Food and Drug Administration (FDA), is the new Vice President of QualityHub Inc., a leading consulting firm* that develops pre- and post-market regulatory and quality systems strategies for the MedTech and pharmaceutical industries.
Until recently Boyd was Director of the Office of Regulatory Programs in the Office of Product Evaluation and Quality (OPEQ), within the FDA’s Center for Devices and Radiological Health (CDRH). While in that post he was responsible for facilitating a slew of MedTech-focused initiatives with a goal of encouraging robust medical device innovation and an uncompromising focus on patient safety. Boyd filled other top roles at the agency over the years, including Deputy Director for Regulatory Affairs in CDRH’s former Office of Compliance and leading many components of the device center’s Radiological Health Program.
“I have a passion for integrating product innovation and safety for the benefit of patients and public health,” Boyd said. “While at the FDA, my aim was to help medical device companies understand and adhere to agency expectations, embrace a culture of quality, and build coalitions around rapidly evolving and complex regulatory frameworks. I’m excited to bring my experience to QualityHub and continue helping manufacturers bring important medical technology to patients worldwide.”
That passion for shaping the future of healthcare will undoubtedly serve Boyd well as he takes on this new critical leadership role at QualityHub, as will his forward-leaning approach to navigating the choppy waters of MedTech regulation, policy, compliance, and enforcement. He is well versed in all aspects of pre-market, post-market, and compliance regulatory reviews across the full spectrum of medical, industrial, commercial, and consumer electronic products and medical devices.
As a now-retired Flag Officer in the US Public Health Service (USPHS) Commissioned Corps, Boyd led preparedness and response efforts that impacted national and global communities during times of crisis. These experiences took him all over the country and to unexpected places including Liberia in 2016, where he was Executive Officer of the Monrovia Medical Unit, which cared for Ebola-infected healthcare workers.
*Founded in 2004 on the principles of quality and a commitment to continuous improvement, QualityHub is a full-service consultancy that provides support in an array of technical areas, including product and quality systems development, auditing, complaint handling, supplier control, clinical compliance, training, and much more. Discover what our FDA compliance consultants, project managers, and regulation experts can do for your medical device or pharmaceutical company at www.qualityhub.com
