FDA & Regulatory Compliance Attorney

micro1; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

micro1 is seeking an FDA & Regulatory Compliance Attorney for a remote contractor role. You will analyze FDA statutes, review regulatory submissions, assess regulatory risk, and draft clear explanations for diverse audiences.

Applicants should hold a JD with an active US license and 5+ years in FDA law or regulatory compliance within life sciences. Strong communication and attention to detail are essential.

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.
• 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.
• Detail-oriented with ability to distill actionable insights from regulatory developments.

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 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

Education

Juris Doctor (JD)

Job description

pay

Required 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

About micro1

micro1 is a data lab that helps AI labs & Enterprises train foundational models and agents. We provide frontier evaluations and reinforcement learning environments to improve LLM capabilities, as well as contextual evaluations to monitor and improve AI agents in enterprise settings.

Our AI recruiting agent sources and vets domain experts for our data platform that enables rapid production of high-quality training data. Our research spans high-value, specialized domains (legal, medical, finance, coding, etc.), where expert-level data is the hardest to produce and most valuable for advanced model performance. Our pipeline performance system ensures both quality and velocity.

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.
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