FDA & Regulatory Compliance Attorney

Role Overview

Apply FDA and regulatory compliance expertise to help improve next-generation AI systems through accurate, practical legal analysis. This remote contract role supports regulatory and legal compliance initiatives by providing high-quality, real-world input. Prior AI experience is not required.

Key Responsibilities

• Analyze and interpret FDA statutes, regulations, and guidance documents.
• Review and critique regulatory submissions, compliance documentation, and procedural materials.
• Evaluate real-world scenarios for regulatory risk, enforcement trends, and liability considerations.
• Draft or edit scenario-based questions and answers that explain regulatory best practices.
• Identify emerging FDA and broader regulatory compliance issues and recommend practical solutions.
• Clearly explain complex legal requirements in writing and verbally for technical and non-technical audiences.
• Provide feedback to improve the accuracy and completeness of project deliverables.

Qualifications

• Juris Doctor degree and an active license to practice law in the United States.
• At least 5 years of experience in FDA law, regulatory strategy, or compliance within life sciences, pharmaceuticals, or medical devices.
• Strong knowledge of FDA regulatory analysis, legal research, regulatory compliance, risk assessment, regulatory submissions, and federal submission pathways and compliance protocols.
• Excellent legal writing, verbal communication, issue-spotting, and problem-resolution skills.
• Ability to translate evolving regulatory developments into actionable insights with close attention to detail.
• Experience advising or representing clients in FDA investigations, warning letters, or consent decrees is preferred.

Work Terms

• Remote, independent contractor engagement.

Compensation

• $140 to $400 per hour.

Application Process

Submit an application through the available application method. Continuing the application confirms acknowledgment of the candidate terms and privacy policy.