Mid-Level Regulatory Attorney

Profile

Job Overview

A law firm seeks a mid-level Regulatory Attorney in Stillwater, MN, to support clients in FDA-regulated industries, including medical device, pharmaceutical, biologic, and diagnostic companies. The role combines FDA regulatory and healthcare compliance work with practical legal advice for clients.

Duties

• Conduct anti-fraud and FDA compliance reviews of promotional materials and commercial programs.
• Draft legal opinions regarding compliance with laws including the FDCA, AKS, FCA, PPSA, and HIPAA.
• Lead FDA meetings and manage regulatory submissions such as 510(k), PMA, IDE, De Novo, and EUA.
• Advise clients on compliant interactions with healthcare professionals and serve on review teams.
• Perform legal research and provide strategic guidance on regulatory matters.

Requirements

• Minimum 5 years of experience in industry (Legal, Compliance, Regulatory Affairs, etc.) or at a law firm serving FDA-regulated clients.
• Demonstrated ability to lead projects and manage multiple assignments in a fast-paced environment.
• Exceptional attention to detail with strong analytical and problem-solving skills.
• Ability to write and speak effectively, persuasively, and concisely.
• Collaborative, business-minded approach with the ability to work with opposing viewpoints.

Education

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

Certifications

• Unrestricted license to practice law in a U.S. state and in good standing.
• Advanced degrees, licenses, or certifications favored (e.g., MD, MBA, PhD, MSc, MPH, RAC, CPA).

Skills

• Strong grasp of healthcare laws and regulations, including FDCA, AKS, FCA, and PPSA.
• Knowledge of FDA regulatory matters, including medical device submissions and advertising review.
• Familiarity with privacy frameworks such as HIPAA, HITECH, GDPR, CCPA, and FTC regulations.
• Proficiency with Microsoft 365 and comfort with adopting AI tools and new technologies.

Benefits

• Competitive compensation and performance-based bonus.
• Flexible work environment and flexible vacation policy.
• Medical, disability, and life insurance benefits.
• 401(k) match.
• Mentoring and coaching opportunities.
• 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