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Remote | FDA & Regulatory Compliance Attorney — $140–$400/hour

Role overview

Qualifications

  • Juris Doctor (JD) degree and active licence to practise law in the United States
  • At least 5 years of professional experience focused on FDA law, regulatory compliance, or regulatory strategy
  • Strong legal expertise within the pharmaceutical, medical device, biotechnology, or broader life sciences industries
  • Excellent legal writing, analytical reasoning, problem-solving, and attention-to-detail skills

Responsibilities

  • Analyse and interpret FDA statutes, federal regulations, guidance documents, and relevant administrative requirements
  • Review and assess FDA regulatory submissions, compliance documentation, and procedural materials
  • Assess realistic legal scenarios involving FDA compliance risks, enforcement trends, and potential liability considerations
  • Develop realistic legal questions, scenario-based exercises, and case studies reflecting FDA regulatory practice

Key facts

Hard skills

Other skills

  • Analytical Thinking
  • Detail Oriented
  • Problem Solving
  • Communication
  • Collaboration

About the company

24-MAG logo

24-MAG

Business Consulting & Services

Company details

IndustryBusiness Consulting & Services
Company size2 - 10

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Job description

We are sharing a specialised remote consulting opportunity for experienced FDA & Regulatory Compliance Attorneys with deep expertise in US food and drug law, life sciences regulation, regulatory strategy, and compliance to contribute their professional knowledge to advanced AI training and evaluation initiatives.

Selected professionals will analyse FDA statutes and regulatory guidance, review compliance documentation, develop realistic legal scenarios, and evaluate AI-generated regulatory content. The work combines legal research, regulatory risk assessment, technical document analysis, and subject-matter evaluation to help improve the accuracy, reasoning, and reliability of AI systems operating across pharmaceuticals, medical devices, and regulated life sciences environments. Prior AI experience is not required.

Key Responsibilities

FDA Regulatory Research & Legal Analysis

  • Analyse and interpret FDA statutes, federal regulations, guidance documents, and relevant administrative requirements
  • Conduct detailed legal research across pharmaceutical, medical device, and broader life sciences regulatory frameworks
  • Evaluate regulatory requirements affecting product development, approval pathways, marketing, and ongoing compliance
  • Examine FDA regulatory interpretations and their implications for regulated organisations and industry practices
  • Apply professional legal judgement to complex regulatory questions involving statutory interpretation and agency guidance

Regulatory Submissions & Compliance Documentation

  • Review and assess FDA regulatory submissions, compliance documentation, and procedural materials
  • Evaluate documentation for accuracy, completeness, regulatory consistency, and alignment with applicable requirements
  • Analyse regulatory submission pathways and associated legal obligations across relevant product categories
  • Identify documentation issues, regulatory inconsistencies, and areas requiring additional legal or technical clarification
  • Provide detailed commentary on regulatory processes, compliance protocols, and documentation quality

Regulatory Risk Assessment & Enforcement Analysis

  • Assess realistic legal scenarios involving FDA compliance risks, enforcement trends, and potential liability considerations
  • Analyse regulatory issues associated with inspections, investigations, enforcement actions, and compliance deficiencies
  • Evaluate legal considerations relating to FDA warning letters, corrective actions, and regulatory remediation
  • Identify emerging regulatory developments and their implications for life sciences organisations
  • Apply risk assessment and issue-spotting expertise to recommend practical, legally grounded approaches to regulatory challenges

AI Training & Regulatory Content Evaluation

  • Develop realistic legal questions, scenario-based exercises, and case studies reflecting FDA regulatory practice
  • Review, edit, and validate AI-generated explanations, regulatory analyses, and compliance-related responses
  • Identify legal inaccuracies, incomplete regulatory reasoning, and areas requiring greater technical or procedural precision
  • Translate complex FDA requirements into clear, structured content suitable for specialised AI training and evaluation
  • Provide constructive written feedback to strengthen the accuracy, completeness, and professional relevance of AI-generated regulatory materials

Legal Quality Assurance & Research Collaboration

  • Produce clear regulatory analyses, legal research summaries, scenario assessments, and structured evaluation feedback
  • Apply rigorous quality standards to materials involving FDA requirements, regulatory submissions, and compliance obligations
  • Communicate complex legal and regulatory concepts effectively to technical and non-technical audiences
  • Collaborate remotely with project stakeholders and other contributors on specialised regulatory research assignments
  • Support the continuous improvement of research methodologies, content accuracy, and overall project deliverable quality

Ideal Profile

  • Juris Doctor (JD) degree and active licence to practise law in the United States
  • At least 5 years of professional experience focused on FDA law, regulatory compliance, or regulatory strategy
  • Strong legal expertise within the pharmaceutical, medical device, biotechnology, or broader life sciences industries
  • Comprehensive understanding of FDA statutes, federal regulations, regulatory guidance, and administrative processes
  • Practical knowledge of regulatory submission pathways, compliance protocols, and agency expectations
  • Demonstrated experience reviewing regulatory documentation, interpreting legal requirements, and conducting detailed legal research
  • Strong ability to identify regulatory risks, compliance deficiencies, and potential liability considerations
  • Experience advising or representing clients in FDA investigations, warning letter responses, or consent decree matters is advantageous
  • Familiarity with emerging regulatory developments and evolving compliance expectations across regulated life sciences sectors
  • Excellent legal writing, analytical reasoning, problem-solving, and attention-to-detail skills
  • Ability to interpret complex or ambiguous regulatory requirements and translate findings into clear, actionable explanations
  • Outstanding written and verbal communication skills, including experience communicating with legal, regulatory, and technical stakeholders
  • Ability to work independently and contribute effectively to remote, collaborative research assignments
  • Prior experience with AI training, model evaluation, or regulatory technology applications is not required

Engagement Details

  • Freelance / contract engagement
  • Fully remote
  • Compensation: $140–$400/hour
  • 5 available openings
  • Specialised legal consulting role spanning FDA law, regulatory compliance, life sciences regulation, and AI training
  • Work will involve regulatory research, legal document review, scenario development, risk assessment, and AI-generated content evaluation
  • Assignments will draw on practical legal expertise in federal regulatory processes, compliance obligations, enforcement considerations, and regulatory submissions
  • Collaboration will take place remotely through designated project communication and workflow tools
  • Prior experience working with AI systems is not required
  • Work must be completed without using confidential or proprietary information belonging to any employer, client, institution, or other third party

About the Platform

This opportunity is available through 24-MAG LLC. We connect experienced professionals with remote consulting opportunities across technical, evaluation, and project-based workstreams.

By submitting this application, you acknowledge that your information may be processed by 24-MAG LLC for recruitment and opportunity matching in accordance with our Privacy Policy: https://www.24-mag.com/privacy-policy

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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