FDA & Regulatory Compliance Attorney - Remote

  • New York, NY, USA
  • Leading Client
  • Contractor
  • Remote
Apply now Refer
Job Description:

Job Title: FDA & Regulatory Compliance Attorney

Role Type: Contractor
Location: Remote

Job Summary

We are seeking experienced FDA & Regulatory Compliance Attorneys to contribute specialized legal expertise to an AI training project. The role involves interpreting FDA regulations, reviewing compliance documentation, assessing regulatory risks, and evaluating AI-generated content for legal accuracy and practical relevance. Prior AI experience is not required.

Key Responsibilities

  1. Analyze and interpret FDA statutes, regulations, and guidance documents to provide specialized legal insights.
  2. Review and evaluate regulatory submissions, compliance documentation, and procedural materials.
  3. Assess real-world scenarios involving regulatory risks, enforcement trends, and potential liability.
  4. Draft and refine scenario-based questions and answers addressing regulatory requirements and best practices.
  5. Identify emerging FDA and regulatory compliance issues and recommend practical solutions.
  6. Explain complex legal and regulatory requirements clearly to technical and non-technical audiences.
  7. Provide feedback to improve the accuracy, completeness, and quality of project deliverables.

Preferred Qualifications

  1. Juris Doctor (JD) degree and active license to practice law in the United States.
  2. Five or more years of experience in FDA law, regulatory strategy, or compliance within life sciences, pharmaceuticals, or medical devices.
  3. Strong understanding of federal regulatory processes, submission pathways, and compliance requirements.
  4. Excellent legal research, analytical, written, and verbal communication skills.
  5. Experience advising or representing clients in FDA investigations, warning letters, or consent decrees is an advantage.
  6. Ability to navigate regulatory ambiguity and translate evolving requirements into actionable insights.
  7. Strong attention to detail and commitment to producing accurate, high-quality legal content.

Ideal Candidate Profile

A detail-oriented legal professional with substantial FDA regulatory expertise, strong compliance knowledge, and the ability to analyze complex regulatory issues and deliver clear, practical, and well-supported legal guidance.