Remote Regulatory affairs Jobs · FDA

• Lead the strategy and execution of regulatory and quality frameworks.
• Oversee regulatory submissions, including 510(k) and De Novo.
• Ensure compliance with FDA, ISO 13485, and MDR.

• Lead site monitoring activities, while also supporting a broad range of clinical responsibilities, including process development, in-house operations, and study oversight.
• Craft, refine, and elevate SOPs, WIs, and operational tools that empower teams and strengthen quality.
• Oversee IRB submissions and maintain a high-quality TMF, ensuring all essential documents are accurate, timely, and inspection-ready.

This 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. This individual monitors and communicates changes in regulatory policies and In Vitro Diagnostic (IVD) requirements to project teams and leadership.

We are seeking an experienced Regulatory Affairs Contractor to support our Human Health Division, specifically focused on medical device regulatory submissions and compliance. This role is ideal for a detail-oriented professional with a strong understanding and experience of global regulatory requirements. This role will prepare, review and submit regulatory documentation for medical devices and ensure compliance with FDA, EU IVDR, and other international regulatory requirements.