FDA & Regulatory Compliance Attorney

• 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.

• 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.

Also listed: verbal communication, attention to detail.

Project and contracting process: the hiring partner. Applications continue on the provider's website.