Attorney - Regulatory

Profile

Job Overview

A law firm seeks a mid-level Attorney specializing in regulatory matters to join their team in the greater Minneapolis/St. Paul area. The role requires an unrestricted license to practice law in a U.S. state, with a preference for admission to any federal district court. The position involves minimal travel and offers a flexible work environment.

Duties

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

Requirements

• 2+ years of experience in a medical device, pharmaceutical, biologic, or diagnostic company.
• Experience with FDA regulatory matters and medical device submissions.
• Knowledge of healthcare laws and regulations, including FDCA, AKS, FCA, and PPSA.
• Ability to lead projects and manage multiple assignments in a fast-paced environment.
• Strong communication and problem-solving skills.

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.
• Advanced degrees or certifications such as MD, MBA, PhD, MSc, MPH, RAC, CPA are favored.

Skills

• Exceptional attention to detail and ethics.
• Ability to work collaboratively and independently.
• Effective and persuasive communication skills.

Benefits

• Flexible work environment.
• Highly competitive compensation package.
• Mentoring and coaching opportunities.
• Commitment to work-life balance, health, and well-being.
• Medical, disability, and life insurance benefits.
• Bonus program and 401(k) match.
• 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