FDA Regulatory Attorney

Job Summary

To assist a global medical technology company, an experienced FDA Regulatory Attorney will engage full-time in a remote role, focusing on FDA regulatory issues, audits, and compliance within the medical device industry.

Key responsibilities

• Manage FDA regulatory issues, including audits and compliance for medical devices
• Provide practical, business-oriented legal advice regarding FDA regulations and standards
• Respond to FDA warning letters and ensure adherence to cGMP standards

Required qualifications

• 8+ years of legal experience with significant FDA medical device regulatory expertise
• Experience in a law firm, in-house legal department, or FDA
• Deep knowledge of the Federal Food, Drug, and Cosmetic Act and related regulations
• Licensed to practice and in good standing in at least one U.S. state bar
• Excellent academic credentials from a U.S. accredited law school