Senior Compliance Attorney

Gardner Law

Minneapolis, Saint Paul (MN, MN)

Hybrid

USD 200,000 - 260,000

Full time

12 days ago

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Benefits offered by this job

Flexible work environment

Health, disability, and life insurance

401(k) with employer match

Professional development support

Job summary

Gardner Law is seeking an experienced Senior Compliance Attorney to join our FDA and health law practice. The role combines healthcare compliance expertise with leadership to guide executive teams, boards, and investors.

The successful candidate will partner with the Compliance Practice Partner, oversee client matters, and help shape strategy, staffing, and growth for the firm’s compliance services.

Qualifications

8+ years 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.
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.

Responsibilities

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 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.
Lead compliance investigations, internal reviews, risk assessments, monitoring programs, and audits.
Review, mentor, and develop attorney work product to maintain high standards of legal analysis and client service.
Conduct due diligence and integration activities in mergers, acquisitions, financings, and investment transactions.
Advise clients regarding enforcement actions, government investigations, whistleblower matters, 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.

Skills

FDA regulatory knowledge

Healthcare compliance

Leadership

Client management

Risk assessment

Mentoring

Business development

Project management

Communication skills

Education

Juris Doctor (ABA-accredited)

Bar admission

Tools

Clio

Adobe & AI-enabled tools

Legal research platforms

E-discovery platforms

Job description

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

Industry: FDA-regulated life sciences

Employment Type: Full-time, Exempt

Reports to: Partner

Travel: 10-20%

THE OPPORTUNITY

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.

WHAT YOU WILL DO

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, whistleblower 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.

WHAT WE ARE LOOKING FOR

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, mentoring, and reviewing attorney work product.
Exceptional written and verbal communication skills.
Juris Doctor from an ABA-accredited law school.
Licensed and in good standing in at least one U.S. jurisdiction.

Preferred qualifications:

Comfort using Microsoft 365 and AI-enabled tools.
Advanced degrees or certifications such as MD, MBA, MPH, RAC, CIPP, CPA.
Experience serving as Chief Compliance Officer, Deputy Compliance Officer, General Counsel, Associate General Counsel, or senior compliance counsel.
Experience advising private-equity-backed and high-growth life sciences companies.

TOOLS YOU WILL USE