Job Description
Responsibilities:
- Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities.
- Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings.
- Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies.
Required Qualifications:
- MS or PhD with 10+ years of experience in regulatory, development, clinical affairs, quality, or program management within the IVD, medical device, or pharmaceutical industries is required.
- Regulatory affairs and IVD device experience required.
- Direct experience with FDA regulatory submissions required.
Preferred Qualifications:
- Experience with regulatory submissions in the EU, Japan, China, Canada, and other international markets is preferred.
- Background in diagnostics or biomarker development, particularly in oncology, is a plus.
- Regulatory Affairs Certification (RAC) preferred.
About GRAIL
GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. They have built a multi-disciplinary organization of scientists, engineers, and physicians and are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.