Associate Director/Director, Regulatory Affairs

Grail in Menlo Park, CA

  • Industry: Executive Management - Marketing/Public Relations
  • Type: Full Time
  • $164,410.00 - 164,410.00
position filled
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 and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit You Will: Develop, prepare, and manage submission of regulatory applications and related supplements and amendments for innovative products.In close collaboration with cross-functional teams, contribute to regulatory strategies for assigned programs and work with internal R&D, Product and Quality teams on execution.As a representative of Regulatory Affairs, work on cross-functional teams and projects, especially those related to software, machine learning, digital health, and artificial intelligence, and provide regulatory guidance and education through the interpretation of laws, regulations, policies, procedures, guidelines, and compliance requirements.Interact directly with regulatory health authorities.Work with others in Regulatory Affairs to train on regulatory requirements and collect and disseminate intelligence on evolving laws, requirements, policies, and trends as relevant to the business.Your Background Will Include: 5+ years of regulatory affairs experience M.S. or Ph.D. in the field of software, physics, engineering, science, or a relevant discipline Experience advising on software regulation Experience in executing regulatory strategy for assigned programsExceptional writing skills with experience in drafting and submitting regulatory submissions to regulatory authorities Cross-functional problem solving skillsExceptional communication and presentation skillsAbility to communicate regulatory requirements to cross-functional teamsExperience in creating and maintaining a corporate culture of complianceQuality System Regulation (and ISO 13485) knowledge preferredRAC credential preferred We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.Menlo ParkRegulatory AffairsFull-Time
Associated topics: care, demand, donor, lead generation, policy, policies, presale, public, twitter, university relationship

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