With almost 20 years of global experience in the biotech, diagnostics, and medical device industries, Brianna brings a wealth of knowledge and expertise to the company’s strategy and execution of its Quality and Regulatory Systems. She is responsible for managing the global regulatory affairs strategies, including the development and submission of product applications for the company’s medical devices, regulatory compliance, and industry advocacy.
Brianna has led multi-disciplinary teams in the implementation and maintenance of multiple divisions of the business, governed by different local, US, and international regulatory agencies such as FDA, EU (IVDR), Canada Health, CAP, CLIA, ISO, and NYS CLEP.
Prior to joining Biodesix, Brianna worked at Covidien Global Business Unit (now Medtronic), where she held Regulatory and Quality Assurance roles for Class II and III medical devices. She was accountable for regulatory compliance, premarket applications, and international product strategies and registrations. Brianna is highly experienced in medical devices, including in vitro diagnostic (IVDs) and the companion diagnostic regulatory environment. She has authored and led project teams to support multiple FDA submissions and other regulatory agencies worldwide.
Brianna is the Chair Elect for the Regulatory Affairs Professionals Society (RAPS) Colorado chapter. She holds an ASQ CQA, Six Sigma Green Belt, and 13485 Lead Auditor certifications and has a Bachelor of Science in Business Management from Indiana Wesleyan University.
Brianna Phillips
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