FDA & Regulatory Compliance Attorney

Micro1; India; A distancia; INR 1.378.000 - 3.444.000; A tiempo parcial

Descripción de la vacante

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.

No prior experience in AI is required— your domain knowledge is what matters. Remote contractor position; you'll analyze statutes, review submissions, assess risk, and draft Q&A to illuminate regulatory best practices for technical and non-technical

Formación

• JD degree and active license to practice law in the United States.
• 5+ years of experience focused on FDA law, regulatory strategy, or compliance.
• Strong understanding of federal regulatory processes and submission pathways.
• Outstanding written and verbal communication with ability to explain complex concepts.

Responsabilidades

• Analyze and interpret FDA statutes, regulations, and guidance documents to provide insights.
• Review and critique regulatory submissions, compliance documentation, and materials.
• Assess real-world scenarios for regulatory risk and liability considerations.
• Draft or edit scenario-based questions and answers elucidating regulatory best practices.
• Identify emerging issues in FDA and regulatory compliance and propose solutions.
• Generate clear explanations of complex regulatory requirements for diverse audiences.
• Contribute to continuous improvement of project deliverables through feedback.

Conocimientos

FDA regulatory analysis

Regulatory strategy

Written communication

Verbal communication

Regulatory compliance

Educación

Juris Doctor (JD)

Descripción del empleo

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.