Litigation Attorney - FDA & Health Law

Gardner Law

Minneapolis (MN)

Remote

USD 150,000 - 190,000

Full time

47 hours ago

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Benefits offered by this job

Hybrid/Remote-friendly environment

401(k) with employer match

Open PTO policy

Healthcare benefits

Job summary

Gardner Law seeks an experienced Litigation Attorney to lead the firm’s practice serving FDA-regulated companies in medical products, foods, and cosmetics. You will manage disputes, regulatory matters, and complex commercial litigation with a client-focused, business-minded approach.

The role requires 5+ years of litigation and strong leadership, with a focus on driving growth and delivering integrated solutions across regulatory and compliance teams.

Qualifications

Former AUSA/SAUSA or HHS-OIG attorney.
5+ years of litigation experience.
Significant first-chair/senior-level experience in complex matters.
Experience representing FDA-regulated companies or similar industries.
Ability to develop litigation strategy, staffing, budgets, and client reporting.
Exceptional oral advocacy, legal writing, negotiation, and problem-solving skills.
Experience serving as primary relationship/ matter attorney for sophisticated clients.
Juris Doctor from ABA-accredited law school and bar admission.

Responsibilities

Lead Gardner Law’s Litigation Practice and serve as lead counsel in disputes involving FDA-regulated products and healthcare.
Collaborate with regulatory, compliance, privacy, and commercial attorneys to deliver integrated client solutions.
Advise executives and boards on litigation risk, crisis management, and dispute-resolution strategies.
Represent clients in commercial disputes, product liability, class actions, and government enforcement actions.
Direct litigation strategy from pre-suit through trial and appeal, including discovery and budgeting.
Build and manage a scalable Litigation Practice with recruiting, procedures, and vendor relationships.
Drive practice growth via client development and cross-practice collaboration.

Skills

AUSA/SAUSA/HHS-OIG attorney

Litigation experience

First-chair leadership

FDA-regulated industry

Litigation strategy & budgeting

Oral advocacy & writing

Executive/board liaison

Team leadership

Juris Doctor

Bar admission & multi-court readiness

Education

Juris Doctor (ABA-accredited law school)

Tools

Microsoft 365

Clio

Adobe

E-discovery platforms

Job description

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%

The Opportunity

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%

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.

What You’ll Do

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.

What We’re Looking For

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 qualifications:

Experience involving FDA, FTC, DOJ, CMS, OIG, OCR, CMS, and/or other regulatory agency investigations and enforcement matters.
Experience handling Food, Drug, & Cosmetic Act, False Claims Act, Anti-Kickback Statute, fraud and abuse, or related healthcare litigation matters.
Established relationships within the FDA-regulated, healthcare, life sciences, or litigation communities, with a demonstrated record of business development.
Prior experience launching, leading, or expanding a litigation practice or other legal service line.
Experience defending product liability, class action, or mass tort litigation.
Federal clerkship experience.
Experience with government investigations, white-collar matters, or criminal enforcement is a plus.

Tools You’ll Use