Associate Director/Director, Regulatory Affairs

05 May, 2020

Jobs

Associate Director/Director, Regulatory Affairs

GRAIL Healthcare
Menlo Park, CA

Associate Director/Director, Regulatory Affairs

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 www.grail.com

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 programs
    • Exceptional writing skills with experience in drafting and submitting regulatory submissions to regulatory authorities
    • Cross-functional problem solving skills
    • Exceptional communication and presentation skills
    • Ability to communicate regulatory requirements to cross-functional teams
    • Experience in creating and maintaining a corporate culture of compliance
    • Quality System Regulation (and ISO 13485) knowledge preferred
    • RAC credential preferred

Learn more here


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.

Job posted: 2020-05-05