Remote FDA Regulatory Counsel (Part-Time, High Pay)

OpenTrain AI, Inc.; United States; Remote; USD 193,000 - 551,000; Part time

Job summary

OpenTrain AI, Inc. is seeking an FDA Regulatory Compliance Attorney (English) to provide legal analysis for AI training projects focused on FDA regulatory compliance. The role requires a U.S.

law license and at least five years of FDA experience, with compensation ranging from $140 to $400 per hour in a remote, part-time capacity. The candidate will review statutes, regulations, submissions, and compliance materials, assess regulatory risk, and draft scenario-based questions and guidance for

Qualifications

• Must have fluent English.
• Active license to practice law in the United States.
• At least five years in FDA law, regulatory strategy, or compliance.
• Background in life sciences, pharmaceuticals, or medical devices.

Responsibilities

• Provide legal analysis for FDA regulatory compliance in AI training projects.
• Review and critique FDA statutes, regulations, and guidance documents.
• Assess regulatory risk, enforcement trends, and liability issues.
• Draft or edit scenario-based questions and answers about regulatory best practices.
• Identify emerging FDA and broader compliance issues and recommend practical solutions.
• Explain complex regulatory requirements to technical and non-technical audiences.
• Provide feedback to improve accuracy and completeness of deliverables.

Skills

FDA regulatory analysis

Regulatory strategy

Legal writing

Regulatory compliance

Job description

OpenTrain AI, Inc. is seeking an FDA Regulatory Compliance Attorney (English) to provide legal analysis for AI training projects focused on FDA regulatory compliance. The role requires a U.S.

law license and at least five years of FDA experience, with compensation ranging from $140 to $400 per hour in a remote, part-time capacity. The candidate will review statutes, regulations, submissions, and compliance materials, assess regulatory risk, and draft scenario-based questions and guidance for