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GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect & identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, & state-of-the-art computer science & data science to enhance the scientific understanding of cancer biology, & to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, & the United Kingdom. GRAIL is a wholly-owned subsidiary of Illumina (NASDAQ:ILMN). For more information, please visit www.grail.com.

Summary:
Leads International regulatory strategy & submission development in partnership with US regulatory & project teams spanning Companion Diagnostics (CDx), Multi-Cancer Early Development (MCED), etc. Interfaces with International regulatory agencies on IVD product registrations & audits. Supports US regulatory team in the development of IDEs, IDE supplements, pre-submissions, PMA, annual reports, etc. Leads regulatory strategy development for GRAIL Laboratory Developed Tests (LDTs) & partners with Quality, Lab Operations, & relevant cross-functional partners to support product validation, audits, review of promotional material, on-market product support, & efficient change control. Monitors & communicates changes in International IVD & US LDT requirements to project teams & leadership. 
 
 
 
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