Regulatory Attorney

Job Overview

A law firm seeks a Regulatory Attorney in the Greater Minneapolis-St. Paul Area. The position offers a flexible work environment with an office located in Stillwater, MN. The role requires a mid-level attorney with an unrestricted license to practice law in a U.S. state.

Duties

• Conduct anti-fraud and FDA compliance reviews of promotional materials and commercial programs.
• Draft opinions regarding compliance with laws such as FDCA, AKS, FCA, and PPSA.
• Participate in FDA meetings and perform legal research.
• Serve on promotional and scientific material review teams.
• Advise clients on compliant interactions with healthcare professionals.
• Make FDA regulatory submissions, including 510(k), PMA, IDE, De Novo, and EUA.

Requirements

• 2+ years of experience in a medical device, pharmaceutical, biologic, or diagnostic company or law firm serving FDA-regulated clients.
• Demonstrated ability to lead projects and manage multiple assignments.
• Responsive, persistent, and capable of working in a dynamic environment.
• Collaborative and business-minded with strong interpersonal skills.
• Exceptional attention to detail and effective communication skills.
• Ability to analyze information quickly and design practical solutions.

Education

• Bachelor of Arts or Bachelor of Science.
• Juris Doctor from an ABA-approved law school.

Certifications

• Licensed and in good standing to practice law in a U.S. state.

Skills

• Strong grasp of ethics laws and the Model Rules of Professional Conduct.
• Experience with FDA regulatory matters and medical device submissions.
• Knowledge of healthcare laws and regulations, including HIPAA and GDPR.
• Proficiency with Microsoft 365 and AI tools.

Benefits

• Flexible work environment.
• Mentoring and coaching opportunities.
• Commitment to work-life balance, health, and well-being.
• Medical, disability, and life insurance benefits.
• 401(k) match and open vacation policy.
• Tuition assistance for work-related certifications and training.

This boutique law firm provides exclusive legal counsel to FDA-regulated companies in medical technology, biotechnology, and pharmaceutical industries. Its practice areas include compliance, ad promo review, sunshine reporting, regulatory, quality, enforcement, clinical, and privacy. Its team of attorneys has decades of experience in these areas. The firm's office is located in Stillwater, Minnesota.