FDA Medical Device Regulatory Attorney (Remote Engagement)

Overview

An experienced FDA regulatory attorney is sought to support a global medical technology company specializing in medical devices, laboratory instruments, and diagnostic products. This is a full-time, remote engagement expected to last 3-6 months.

Responsibilities

• Provide legal guidance on FDA regulatory matters related to medical devices
• Handle FDA audits and ensure compliance with cGMP standards
• Respond to FDA warning letters and other regulatory communications
• Advise on Federal Food, Drug, and Cosmetic Act compliance, Quality System Regulation (QMSR), clinical investigations, advertising and promotion, and post-market compliance
• Manage multiple complex projects simultaneously

Requirements

• Minimum 8 years of legal experience with significant focus on FDA medical device regulatory issues
• Experience working in a law firm, in-house legal department, FDA, or a combination thereof
• Deep knowledge of FDA regulations including the Federal Food, Drug, and Cosmetic Act, QMSR, clinical investigations, advertising and promotion, and post-market compliance
• Licensed to practice law and in good standing in at least one U.S. state bar
• Excellent academic credentials from a U.S. accredited law school
• Strong written and verbal communication skills
• Ability to provide practical, business-oriented legal advice

Position Details

• Role Type: Contract engagement
• Schedule: Full-time
• Duration: 3-6 months
• Location: Fully remote

Compensation & Benefits

• Salary range: $220,000 - $250,000 (full-time equivalent)
• Pay for contract engagements is influenced by experience, qualifications, location, market conditions, and candidate preferences
• Complimentary professional liability insurance coverage for work performed within the scope of the engagement
• Eligibility for full benefits when working 20+ hours per week, including group medical, dental, and vision insurance
• Complimentary group life, long-term disability (LTD), and accidental death & dismemberment (AD&D) insurance
• Qualified 401(k) plan available
• Continuing Legal Education (CLE) and professional expense stipends for benefits-eligible attorneys

Confidentiality

Candidates will not be proposed to clients without prior consent. Only those selected for further consideration will be contacted.

Location

This is a fully remote position.