GRAIL

Regulatory Affairs Associate Director

GRAIL

full-time

Posted on:

Origin:  • 🇺🇸 United States • California

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Salary

💰 $164,000 - $205,000 per year

Job Level

Senior

About the role

  • 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 Menlo Park, California, with locations in Washington, D.C., North Carolina, and the United Kingdom.
  • For more information, please visit grail.com.
  • The role assists with regulatory strategy and the development of submissions in partnership with key internal and external stakeholders for GRAIL projects, including Multi-Cancer Early Detection (MCED).
  • The position supports the U.S. Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual reports, and other relevant documentation.
  • The role collaborates cross-functionally with Quality, Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market product support, and change control processes.
  • This individual monitors and communicates changes in regulatory policies and In Vitro Diagnostic (IVD) requirements to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate.
  • The role fosters a work culture aligned with GRAIL’s values

Requirements

  • Minimum of 8 years of experience in regulatory, development, clinical affairs, quality, or program management within the IVD, medical device, or pharmaceutical industries
  • Regulatory affairs and IVD device experience preferred
  • An advanced degree may count toward years of experience
  • Direct experience with FDA regulatory submissions required
  • 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
  • Advanced scientific degree preferred
  • Regulatory Affairs Certification (RAC) preferred
  • Experience in pharmaceutical clinical, statistical, or regulatory settings—especially in oncology, immunology, or related fields—is a plus