FDA & Regulatory Compliance Attorney

Confidential; United States; Remote; USD 110,000 - 207,000; Full time

Job summary

Zekai is seeking a FDA & Regulatory Compliance Attorney for a fully remote contract role. You will collaborate on regulatory and legal compliance initiatives, applying your expertise to support AI training and compliance with FDA rules.

This role requires a JD and US licensure, 5+ years in FDA law or regulatory affairs, and strong written and verbal skills to explain complex requirements to technical and non-technical audiences.

Qualifications

• JD and active US law license.
• 5+ years focused on FDA law or regulatory compliance.
• Strong understanding of federal regulatory processes.

Responsibilities

• Analyze FDA statutes, regulations, and guidance for insights.
• Review regulatory submissions and compliance docs.
• Assess regulatory risk in real-world scenarios.
• Draft scenario-based questions and answers on best practices.
• Identify emerging FDA issues and propose practical solutions.
• Explain complex legal requirements clearly to diverse audiences.
• Improve project deliverables through content feedback.

Skills

Regulatory analysis

Legal drafting

FDA law

Communication skills

Risk assessment

Education

Juris Doctor (JD)

Job description

Role Title: FDA & Regulatory Compliance Attorney

Role Type: Contractor

Location: Remote

our partner is engaging FDA & Regulatory Compliance Attorneys to collaborate on a project supporting regulatory and legal compliance initiatives for a valued customer. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required - your domain knowledge is what matters.

Scope of Work

• Analyze and interpret FDA statutes, regulations, and guidance documents to provide domain-specific insights.
• Review and critique regulatory submissions, compliance documentation, and procedural materials.
• Assess real-world scenarios for regulatory risk, enforcement trends, and liability considerations.
• Draft or edit scenario-based questions and answers elucidating regulatory best practices.
• Identify emerging issues in FDA and broader regulatory compliance and recommend practical solutions.
• Generate clear, concise written and verbal explanations of complex legal requirements for technical and non-technical audiences.
• Contribute to the continuous improvement of project deliverables through feedback on content accuracy and completeness.

Preferred Qualifications

• Juris Doctor (JD) degree and active license to practice law in the United States.
• 5+ years of experience focused on FDA law, regulatory strategy, or compliance in life sciences, pharmaceuticals, or medical devices.
• Strong understanding of federal regulatory processes, submission pathways, and compliance protocols.
• Outstanding written and verbal communication skills, with proven ability to convey complex legal concepts clearly.
• Experience advising or representing clients in FDA investigations, warning letters, or consent decrees is advantageous.
• Ability to navigate ambiguity and distill actionable insights from regulatory developments.
• Detail-oriented approach and commitment to producing high-quality, accurate content.

This is a 100% remote contract role, open to applicants worldwide in the countries the employer accepts.