Associate Director, Quality Labeling Operations # 4648

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we 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. GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit grail.com The Associate Director, Quality Labeling Operations is responsible for establishing, implementing, maintaining, and continuously improving GRAIL’s product labeling program. This role partners closely with Regulatory Affairs, Operations, Marketing, Supply Chain, R&D, Clinical Laboratory, Clinical Operations, and Design/Artwork to lead the global product labeling controls for GRAIL’s regulated in vitro diagnostic (IVD) medical devices. This individual contributor role is the SME responsible for the development, implementation, and lifecycle management of compliant product labeling content, including Instructions for Use (IFU), Unique Device Identifier (UDI) labeling, and other product labeling elements required under FDA, EU IVDR/MDR, and U.K. MHRA regulations. The individual applies critical thinking and sound judgment to solve broad, complex problems and regularly communicates status, risks, and recommendations to management.   Primary responsibilities include providing expertise and oversight to ensure GRAIL’s product labeling operations achieve and maintain compliance with the EU In Vitro Diagnostic Regulation (IVDR), ISO 13485:2016, ISO 14971:2019, 21 CFR 801, 21 CFR 820, 21 CFR 809, Unique Device Identifier (UDI) requirements and related in vitro diagnostic medical device regulations.     This role is based at our Durham, North Carolina, office. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site.