Litigation Attorney - FDA & Health Law

Location: Flexible/Remote (Gardner Law has offices in Minnesota, Texas, Michigan, and Massachusetts)

Industry: FDA and Health Law Firm Serving Medical Products, Foods, & Cosmetics Companies

Employment Type: Full-time, exempt

Reports to: Managing Partner

Travel: 10-20%

Location: Flexible/Remote (Gardner Law has offices in Minnesota, Texas, Michigan, and Massachusetts)

Industry: FDA and Health Law Firm Serving Medical Products, Foods, & Cosmetics Companies

Employment Type: Full-time, exempt

Reports to: Managing Partner

Travel: 10-20%

Gardner Law is seeking an experienced Litigation Attorney to lead and develop the firm’s Litigation Practice serving FDA-regulated companies in the medical products, foods, and cosmetic industries.

This role is ideal for an experienced litigator who combines exceptional advocacy skills with strategic business judgment and the ability to build and lead a litigation practice serving FDA-regulated organizations. The candidate will have responsibility for leading Gardner Law’s Litigation Practice, including evaluating new cases, advising and defending clients in litigation, government investigations, regulatory enforcement matters, arbitration proceedings, and complex commercial disputes.

The Litigation attorney will collaborate closely with Gardner Law’s regulatory, compliance, and privacy attorneys to provide practical, business-minded advice grounded in sound judgment and a client-service approach that builds trust and advances client objectives.

• Lead Gardner Law’s Litigation Practice and serve as lead counsel in disputes involving FDA-regulated products, healthcare companies, and other regulated industries.
• Collaborate with regulatory, compliance, privacy, and commercial attorneys to deliver integrated, business-minded client solutions.
• Advise executives and boards on litigation risk, crisis management, internal investigations, and dispute-resolution strategies.
• Represent clients in commercial disputes, product liability claims, class actions, False Claims Act matters, and other healthcare enforcement actions.
• Defend clients in courts, arbitrations, administrative proceedings, and investigations involving FDA, DOJ, FTC, CMS, OIG, and related agencies.
• Direct litigation strategy from pre-suit assessment through trial, settlement, and appeal, including discovery, motions, experts, staffing, budgets, and outside resources.
• Build and manage a scalable Litigation Practice, including recruiting and mentoring professionals and developing procedures, technology, vendor relationships, and quality standards.
• Drive practice growth through client development, cross-practice collaboration, thought leadership, industry engagement, and sound financial management.

Essential qualifications:

• Former Assistant United States Attorney (AUSA) or former Special Assistant United States Attorney (SAUSA), or former HHS-OIG attorney.
• 5+ years of litigation experience in a law firm, government, or in-house legal department, including experience leading significant matters and litigation teams.
• Significant first-chair or senior-level experience handling complex commercial litigation and regulatory disputes, including motions, depositions, hearings, arbitrations, trial preparation, and trials.
• Experience representing FDA-regulated companies, healthcare organizations, manufacturers, life sciences companies, or similarly regulated industries, with strong knowledge of federal and state civil procedure.
• Proven ability to develop litigation strategy, staffing plans, budgets, and client reporting while managing experts, vendors, local counsel, and other resources.
• Exceptional oral advocacy, legal writing, negotiation, strategic thinking, risk assessment, and problem-solving skills.
• Experience serving as the primary relationship and matter attorney for sophisticated clients, including senior executives, boards, and in-house legal teams.
• Demonstrated success leading litigation teams, managing quality and client service across multiple matters, developing business, and determining when Gardner Law should handle matters directly, build internal capabilities, or collaborate with additional counsel.
• Juris Doctor from an ABA-accredited law school.
• Licensed and in good standing in at least one U.S. jurisdiction, with admission to one or more federal courts and the ability to obtain admission in additional courts or appear pro hac vice as matters require.

Preferred…