Gardner Law ยท 1 week ago
Compliance Attorney
Twin Cities Area
Full-time
Hybrid
Entry, Mid Level
$150K/yr - $225K/yr
2+ years expGardner Law is an FDA law firm that specializes in regulatory, compliance, privacy, litigation, and commercial matters. They are seeking a Compliance Attorney to train teams on healthcare compliance, advise clients on regulatory matters, and enhance compliance programs.
Responsibilities
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
Qualification
Required
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
Knowledge of privacy laws and regulations (e.g., HIPAA, HITECH, GDPR, CCPA, and FTC)
Comfort using Microsoft 365 and AI-enabled tools; adaptable to new technologies
Advanced degrees or certifications (e.g., MD, MBA, MPH, RAC, CIPP, CPA)
Benefits
Flexible work environment.
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.
Company
Gardner Law
Gardner Law is an FDA law firm specializing in regulatory, compliance, privacy, commercial transaction, and litigation matters.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Tracy Erickson MAcc, C.P.A. (inactive)
Chief Financial Officer & Chief Operating Officer
Company data provided by crunchbase