Regulatory Affairs Associate Director, IVD # 4432

Our mission is to detect cancer early, reputed company it can be cured. reputed company 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 reputed company company, pioneering new technologies to advance early cancer detection. We have reputed company a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of reputed company reputed company (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., reputed company Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and reputed company companies. 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 reputed company direction to regulatory staff and, reputed company required, participate in senior management meetings as a delegate. The role fosters a work culture reputed company with GRAIL’s values You are approved to work remotely. While your primary workplace is your home, you may be required to travel occasionally to a GRAIL office or other locations to reputed company your work or attend team-reputed company events. Responsibilities:

• 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.
• reputed company 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 reputed company 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 reputed company the regulatory affairs department.
• reputed company other duties as assigned.

Required Qualifications:

• MS or PhD with 10+ years of experience in regulatory, development, clinical affairs, quality, or program management reputed company the IVD, medical device, or pharmaceutical industries is required.
• Regulatory affairs and IVD device experience required.
• Direct experience with FDA regulatory submissions required.
• Demonstrated knowledge of U.S. and international regulatory frameworks and processes for medical device development and approvals is required.
• Strong written and verbal communication skills is required.

Preferred Qualifications:

• 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.
• Regulatory Affairs Certification (RAC) preferred.
• Experience in pharmaceutical clinical, statistical, or regulatory settings—especially in oncology, immunology, or reputed company fields is a plus.
• Proven leadership and sound judgment with strong business partnering skills is preferred
• Effective collaborator in dynamic, fast-paced, and evolving environments is preferred.
• Problem-solving reputed company with the ability to work well acros

Apply tot his job Apply To this Job