Regulatory Affairs Associate Director, IVD

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. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

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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

This job requires that a minimum of 60% or 3 days of the total work week be onsite in Durham, NC.

• Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities.

• Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k) s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings.

• Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies.

• Provide regulatory support for both new and marketed Laboratory Developed Test (LDT) products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval.

• Monitor and report on international regulatory developments and LDT requirements that may significantly impact business operations or customers.

• Maintain up-to-date knowledge of applicable regulatory requirements and relevant scientific/technical developments.

• Identify regulatory risks and propose alternative courses of action.

• Assess new regulations and collaborate with internal teams to implement appropriate changes.

• Support internal and external quality audits.

• Ensure compliance with all regulations and laws applicable to GRAIL's business, providing guidance and recommendations.

• Review and approve regulatory strategy documents, regulatory plans, procedures, SOPs, and other documents for alignment with commitments, regulations, and filings.

• Manage the creation and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department.

• Perform other duties as assigned.

• Experience

• Minimum of 10 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…