Bryce Whited
About Bryce Whited
Bryce Whited serves as the Vice President of US Regulatory Affairs at Nox Health, bringing extensive experience in biomedical engineering and regulatory affairs. He has held various leadership positions in the medical device industry and has a strong academic background, including a Ph.D. in Biomedical Engineering.
Work at Nox Health
Bryce Whited has been serving as the Vice President of US Regulatory Affairs at Nox Health since 2020. In this role, he is responsible for overseeing regulatory strategies and compliance for the company's products in the United States. His extensive background in regulatory affairs enables him to navigate complex regulatory landscapes effectively, ensuring that Nox Health meets all necessary requirements for product development and market entry.
Education and Expertise
Bryce Whited holds a Ph.D. in Biomedical Engineering from Wake Forest University, which he completed from 2009 to 2012. He also earned a Master of Science in Biomedical Engineering from Wake Forest University between 2003 and 2005. Additionally, he obtained a Bachelor of Science in Materials Science and Engineering from Virginia Tech from 1998 to 2003. His educational background provides a strong foundation for his expertise in regulatory affairs, particularly in medical devices and combination products.
Background
Bryce Whited has a diverse professional background in regulatory affairs, having worked in various capacities across multiple organizations. Prior to joining Nox Health, he served as Vice President of Medical Devices & Combination Products at The Weinberg Group from 2018 to 2020. His earlier roles include positions at BIOTRONIK, where he held several regulatory affairs management roles, and at Contego Medical, LLC as Director of Regulatory Affairs. He also has experience with the U.S. Public Health Service Commissioned Corps and the FDA.
Achievements
Bryce Whited has a strong track record in regulatory submissions, including original PMA, PMA Supplement, original IDE, IDE supplement, 510(k), De Novo, and HUD designations. He is experienced in coordinating FDA pre-submission, Pre-IND, and Pre-NDA meetings. His technical expertise supports device and combination product bench and preclinical testing programs. Additionally, he has authored high impact factor journal articles and has been a speaker at national and international scientific conferences.
Regulatory Knowledge and Skills
Bryce Whited possesses extensive knowledge of regulatory standards and guidelines, including ICH Drug Stability guidelines, 21 CFR 820, 21 CFR 4, and ISO 13485:2016. He is well-versed in the development and regulation of electrical devices and software applications, including SaMD and mobile medical applications. His experience includes managing EU Class II and Class III device technical file documentation, complaint handling, and vigilance reporting, which are critical aspects of regulatory compliance.