Reports to: Partner

Industry: Law Practice (FDA-regulated industry)

Employment Type: Full-time

Location: Flexible (office located in greater Minneapolis/St. Paul area)

Licensure: Unrestricted license to practice law in a U.S. state

Preferred License: Admission to any federal district court

Level: Mid-level

Exempt Status: Exempt

Hours of Work: Varies

Travel Required: Yes (minimal, e.g., <5%)

Essential Qualifications:

• 2+ years of experience advising or working within the medical device, pharmaceutical, biologic, or diagnostic industry, either in-house (e.g., Legal, Regulatory Affairs, Compliance) or in a law firm serving FDA-regulated clients.
• Experience with U.S. health care compliance laws and regulations (e.g., Food, Drug and Cosmetic Act (FDCA), Anti-Kickback Statute (AKS), False Claims Act (FCA), and Physician Payments Sunshine Act (PPSA)).
• Experience with health care anti-fraud compliance matters, e.g., health care compliance auditing and monitoring experience.
• Experience with FDA regulatory matters, including advertising and promotion review.
• Strong risk assessment and issue-spotting skills; ability to design practical, business-aligned solutions.
• Demonstrated ability to advise clients directly and communicate complex concepts clearly and persuasively.
• Experience drafting and delivering compliance policies, procedures, and training.
• Demonstrates ability to lead projects and teams.
• Responsive, persistent, and capable of managing multiple priorities in a fast-paced environment.
• Flexible, independent, and self-starting.
• Collaborative, business-minded, and professional under pressure.
• Exceptional attention to detail.
• Excellent written and verbal communication skills.
• Juris Doctor (or equivalent) from an ABA-accredited law school.
• Licensed and in good standing to practice law in a U.S. state.
• Strong grasp of ethics laws and the Model Rules of Professional Conduct.

Preferred Qualifications:

• Advanced degrees or certifications (e.g., MD, MBA, MPH, RAC, CIPP, CPA)
• Comfort using Microsoft 365 and AI-enabled tools; adaptable to new technologies.
• Knowledge of privacy laws and regulations (e.g., HIPAA, HITECH, GDPR, CCPA, and FTC).

Primary Functions:

• Training leadership, field teams, and compliance committees on U.S. healthcare compliance requirements.
• Reviewing promotional, scientific exchange, and related materials for FDA and anti-fraud compliance (MLR/PRC).
• Advising clients on compliant HCP interactions, speaker programs, and consulting arrangements.
• Evaluating sales, marketing, and reimbursement programs for compliance with FDA, CMS, OIG, OCR, and FTC regulations.
• Designing, implementing, and enhancing compliance programs and policies.
• Serving as outsourced or interim Compliance Officer for clients.
• Conducting compliance audits, monitoring activities, and internal investigations.
• Supporting due diligence, integration, and risk assessments for M&A and investment transactions.
• Managing responses to competitor complaints, whistleblower matters, and regulatory inquiries.
• Collaborating with teammates across regulatory, privacy, and commercial disciplines to deliver high-quality client work on time.

Tools:

• Microsoft 365 (Teams, Outlook, Copilot).
• Proficiency with AI tools.
• Comfortable adopting and learning new technologies.

Benefits:

• Flexible work environment.
• Competitive compensation in the range of $150,000 and up, plus performance-based bonus.
• Opportunity to be a part of a high-performing, distinguished team.
• Mentoring and coaching opportunities (giving and receiving).
• Firm commitment to work-life balance, health, and well-being.
• Medical, disability, and life insurance benefits.
• Bonus program.
• 401(k) match.
• Open vacation.
• Tuition assistance for work-related certifications and training.
• Trail-blazing best-in-class clientele.

Words our employees use to describe Gardner Law:

• Rewarding.
• Great work-life balance.
• Variety in work and clientele.
• Collaborative.
• Flexible.
• Independent.
• Fast-paced.
• Impactful.
• Focused on FDA-regulated industry.
• Employee growth-oriented.
• Opportunity for growth and advancement.

About Gardner Law

Gardner Law is an FDA law firm that specializes in regulatory, compliance, privacy, litigation, and commercial matters. Improving health and enhancing lives is our purpose at Gardner Law and it guides everything we do.

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