About this opportunity
Confidential lists this FDA & Regulatory Compliance Attorney opportunity in Needham Heights, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Role Overview
Apply FDA and regulatory compliance expertise to help improve next-generation AI systems through accurate, practical legal analysis. This remote contract role supports regulatory and legal compliance initiatives by providing high-quality, real-world input. Prior AI experience is not required.
Key Responsibilities
Analyze and interpret FDA statutes, regulations, and guidance documents.
Review and critique regulatory submissions, compliance documentation, and procedural materials.
Evaluate real-world scenarios for regulatory risk, enforcement trends, and liability considerations.
Draft or edit scenario-based questions and answers that explain regulatory best practices.
Identify emerging FDA and broader regulatory compliance issues and recommend practical solutions.
Clearly explain complex legal requirements in writing and verbally for technical and non-technical audiences.
Provide feedback to improve the accuracy and completeness of project deliverables.
Qualifications
Juris Doctor degree and an active license to practice law in the United States.
At least 5 years of experience in FDA law, regulatory strategy, or compliance within life sciences, pharmaceuticals, or medical devices.
Strong knowledge of FDA regulatory analysis, legal research, regulatory compliance, risk assessment, regulatory submissions, and federal submission pathways and compliance protocols.
Excellent legal writing, verbal communication, issue-spotting, and problem-resolution skills.
Ability to translate evolving regulatory developments into actionable insights with close attention to detail.
Experience advising or representing clients in FDA investigations, warning letters, or consent decrees is preferred.
Work Terms
Remote, independent contractor engagement.
Compensation
$140 to $400 per hour.
Application Process
Submit an application through the available application method. Continuing the application confirms acknowledgment of the candidate terms and privacy policy.
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.