Senior Compliance Attorney

Location: Flexible/Remote (office in Stillwater, MN)

Industry: FDA-regulated life sciences

Employment Type: Full-time, Exempt

Reports to: Partner

Travel: 10-20%

Gardner Law is seeking an experienced Senior Compliance Attorney to join our growing FDA and health law firm specializing in regulatory, compliance, privacy, commercial, and litigation.

This is a leadership role for an attorney who combines deep healthcare compliance experience with strong business judgment, client-management skills, and a desire to help build a premier FDA & Health law practice. The successful candidate will serve as a trusted advisor to executive leadership teams, compliance officers, boards of directors, and private equity-backed companies while helping mentor attorneys and support the continued growth of the firm's Compliance Practice.

The successful candidate will serve as a strategic partner to the Partner leading the firm's Compliance Practice and help oversee key client relationships, legal strategy, practice development, staffing, and the continued growth of the practice.

• Serve as a strategic thought partner to the Partner leading the Compliance Practice, helping oversee client matters, legal strategy, staffing, and practice growth.
• Independently manage key client relationships and serve as primary outside compliance counsel for FDA-regulated companies.
• Serve as lead counsel on complex healthcare compliance and regulatory matters.
• Advise executive teams, boards of directors, compliance committees, and investors on strategic compliance risks and opportunities.
• Review and provide strategic guidance on promotional materials, scientific exchange activities, and advertising and promotion matters.
• Counsel clients regarding Anti-Kickback Statute, False Claims Act, Sunshine Act, FDA requirements, Medicare and Medicaid compliance, and related healthcare laws.
• Design, implement, assess, and enhance enterprise compliance programs.
• Serve as outside Chief Compliance Officer or strategic compliance advisor for select clients.
• Lead compliance investigations, internal reviews, risk assessments, monitoring programs, and audits.
• Review, mentor, and develop attorney work product to maintain the firm's high standards of legal analysis, practicality, and client service.
• Conduct compliance due diligence and integration activities in mergers, acquisitions, financings, and investment transactions.
• Advise clients regarding enforcement actions, government investigations, whistle blower matters, competitor complaints, and regulatory inquiries.
• Develop and deliver executive training, board presentations, and compliance education programs.
• Collaborate with attorneys across regulatory, privacy, litigation, and commercial disciplines.
• Contribute to and lead business development through client relationships, thought leadership, publications, industry presentations, and networking.

• 8+ years of experience advising FDA-regulated companies on healthcare compliance, legal, regulatory, and business-risk matters.
• Experience advising executive leadership teams, boards of directors, compliance committees, and investors on complex regulatory and compliance matters.
• Significant experience advising medical device, pharmaceutical, biologic, diagnostic, or other FDA-regulated companies, including substantial in-house experience and/or dedicated outside counsel experience supporting legal, compliance, regulatory, commercial, and executive leadership teams.
• Deep knowledge of healthcare compliance and FDA regulatory requirements, including the FDCA, AKS, FCA, CMS requirements, OIG guidance, transparency laws, and related healthcare compliance frameworks.
• Extensive experience designing, implementing, auditing, and enhancing compliance programs.
• Experience leading internal investigations, compliance monitoring programs, and risk assessments.
• Strong client-management skills and demonstrated ability to serve as a trusted advisor to senior leadership.
• Exceptional issue-spotting, judgment, and practical risk-management capabilities.
• Experience managing complex legal projects and coordinating multidisciplinary teams.
• Strong leadership, mentoring, and talent-development skills.
• Proven ability to independently manage sophisticated client matters, prioritize competing demands, and deliver practical, business-oriented advice in a fast-paced environment.
• Demonstrated business-development capabilities and ability to expand client relationships.
• Experience supervising,…