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micro1

FDA & Regulatory Compliance Attorney

Remote
Contract
Mid-level
Subject Matter Experts
M
micro1
Location
Remote · Remote
Employment
Contract
Experience
Mid-level
Category
Subject Matter Experts
Pay
$140–$400/hr
Languages
—
Posted
18 days ago
micro1

Bangladesh, Hong Kong, India +55 more

5 openings

Last seen 11 hours ago

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About the opportunity

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.

Skills

fda regulatory analysis
legal research
regulatory compliance
risk assessment
regulatory submissions
legal writing
verbal communication
life sciences industry knowledge
attention to detail
issue spotting and resolution

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