FDA & Regulatory Compliance Attorney

Parailabs; États-Unis; À distance; USD 83 000 - 124 000; Temps partiel

Résumé du poste

Parailabs is seeking a remote FDA & Regulatory Compliance Attorney to support regulatory and legal compliance initiatives for a valued customer. You will apply your domain knowledge to help train next-generation AI systems and provide clear, practical guidance on complex regulatory matters.

The role requires a JD with an active license in the United States and 5+ years of experience in FDA law or regulatory compliance within life sciences, pharmaceuticals, or medical devices.

Qualifications

• JD required with 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.

Responsabilités

• 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.

Connaissances

FDA law

Regulatory strategy

Life sciences

Regulatory compliance

Formation

Juris Doctor (JD) degree

Description du poste

Role Title: FDA & Regulatory Compliance Attorney

Role Type: Contractor

Location: Remote

micro1 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.