Regulatory Attorney

Profile

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.

Company info

BCG Attorney Search
200 South Wacker Drive, 31st Floor
Chicago
Illinois
United States 60606
Phone : (312) 321-9411
Fax : (213) 895-7306