Remote Regulatory affairs Jobs · US

• 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.

The Director Regulatory Advertising and Promotion N.A is responsible for providing strategic and tactical regulatory ad promo support and guidance related to product and disease state communications for assigned product(s) or therapeutic area across the product life cycle. As the internal subject matter expert on FDA regulations of prescription drug advertising and promotion, this role collaborates extensively with cross-functional teams to ensure that promotional communications are compliant and meet business objectives. The incumbent will serve as the primary liaison with the FDA’s office of prescription Drug Promotion (OPDP).

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.

Lead and execute the regulatory strategy for CAR T programs, serving as the primary regulatory representative, guiding activities across preclinical, clinical, and manufacturing stages, partnering with internal teams and external partners. Work cross-functionally with Clinical, CMC, Quality, and Patient Operations to plan and manage regulatory submissions, including INDs, IND amendments, and meeting packages. The ideal candidate brings experience in Regulatory Affairs within a clinical-stage biotech.

Responsible for building and leading cross-functional quality assurance systems across Loyal teams with an emphasis on FDA-CVM regulatory compliance for drug submissions and products. The work will ensure that all aspects of drug development and clinical operations are high quality, and that any deviations from this are investigated and understood. You will report to our VP of Regulatory and QA.

Responsible for building and leading cross-functional quality assurance systems across Loyal teams with an emphasis on FDA-CVM regulatory compliance for drug submissions and products. This role ensures all aspects of drug development, manufacturing and clinical operations are high quality, and that any deviations from this are investigated and understood. The Quality Compliance Officer is responsible for maintaining and continuously improving the company’s Quality Management System (QMS).

Seeking a detail-oriented and motivated RA/QA professional to support key regulatory and quality activities within our client's medical device operations. This individual will assist with CAPA management, vendor oversight, documentation control, and other compliance-related tasks. Experience with Software as a Medical Device (SaMD) is a plus.