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Brianna Phillips is the Vice President of Quality and Regulatory Affairs at Biodesix, a leading biotech company in the healthcare industry. With over 16 years of global experience in the biotech, diagnostics, and medical device industries, Brianna brings a wealth of knowledge and expertise to her role. 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, NYS CLEP, etc. 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.
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 a decisive and resourceful leader who fosters a culture of teamwork and dedication to excellence. She prides herself on being a dynamic professional that can identify and implement solutions to complex problems with a hands-on, lead-by-example management style. Brianna is the recipient of the Biodesix “I Am Biodesix” Award, recognized by both her peers and leadership for her dedication to the team. Brianna is also a Vice President on the board of a local Boulder-based non-profit charity that is passionate about equal opportunities and advancing education opportunities for underprivileged and minority children.
Brianna’s focus is on ensuring Biodesix products and QMS maintain the highest level of compliance and regulatory approvals by establishing a "Best in Class" globally certified medical laboratory and biorepository.
