FDA & Regulatory Compliance Attorney

Remotebridge; United States; Remote; USD 150,000 - 210,000; Part time

Job summary

Remotebridge is seeking a contractor FDA & Regulatory Compliance Attorney to analyze FDA statutes, regulations, and guidance, and to review submissions and compliance materials. You will assess regulatory risk and draft scenario-based questions illustrating best practices, delivering clear explanations to technical and non-technical audiences.

The role requires a JD with active US licensure and 5+ years in FDA law or regulatory compliance within life sciences, pharmaceuticals, or medical

Qualifications

• JD degree and active license to practice law in the United States.
• 5+ years of FDA law, regulatory strategy, or compliance experience 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 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 high-quality, accurate content.

Responsibilities

• 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.

Skills

FDA law

Regulatory strategy

Regulatory compliance

Written communication

Verbal communication

Regulatory risk analysis

Education

Juris Doctor (JD) degree

Active US law license

Job description

Role Title: FDA & Regulatory Compliance Attorney

Role Type: Contractor

Location: Remote

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.