Careers

Please send a resume and cover letter to Tracy Erickson at terickson@gardner.law with the subject line "Regulatory Attorney Applicant," and submit an application on LinkedIn.

The Opportunity

Gardner Law is seeking a mid-level Regulatory Attorney to support clients in FDA-regulated industries, including medical device, pharmaceutical, biologic, and diagnostic companies. The role combines FDA regulatory and healthcare compliance work with practical legal advice for clients.

The successful candidate will bring strong analytical and communication skills, a collaborative and business-minded approach, and the ability to manage multiple assignments in a flexible work environment.

What You’ll Do

• Anti-fraud and FDA compliance review of promotional materials and commercial programs.
• Drafting opinions regarding compliance with laws including: FDCA, AKS, FCA, PPSA & HIPAA.
• FDA meetings.
• Performing research.
• Serving on promotional material and scientific material review teams.
• Advising clients on compliant interactions with health care professionals.
• Making FDA regulatory submissions (e.g., 510(k), PMA, IDE, De Novo, EUA).

What We Are Looking For

Essential qualifications:

• 5+ years of experience working in industry at a medical device, pharmaceutical, biologic, or diagnostic company, e.g., working in Legal, Compliance, Regulatory Affairs, Quality Affairs, Clinical Affairs, Product Management, R&D, or in a law firm serving FDA-regulated clients.
• Demonstrates ability to lead projects.
• Responsive, persistent, and capable of managing numerous assignments and responsibilities simultaneously in a dynamic and fast-paced environment while meeting goals and deadlines.
• Flexible, independent, and self-starting.
• Collaborative, business-minded, and not combative.
• Ability to work productively with individuals with opposing viewpoints and strong personalities, including company lawyers, executives, and regulators.
• Exceptional attention to detail.
• Ability to write and speak in an effective, persuasive, and concise manner.
• Ability to analyze disparate information quickly and design effective and practical solutions to problems.
• Bachelor of Arts or Bachelor of Science.
• Juris Doctor (or equivalent) from an ABA-approved law school.
• Licensed and in good standing to practice law in a U.S. state.
• Strong grasp of and attention to ethics laws and the Model Rules of Professional Conduct.

Preferred qualifications:

• Experience with FDA regulatory matters, including medical device submissions, regulatory strategy, and advertising and promotion review and processes.
• Possess medical device submission (e.g., 510(k), PMA, IDE, De Novo, EUA) and advertising and promotion review knowledge.
• Knowledge of health care 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)).
• Demonstrated ability to lead FDA meetings on behalf of industry.
• Knowledge of HIPAA, HITECH, GDPR, CCPA, and FTC privacy frameworks.
• Advanced degrees, licenses, certifications favored, e.g., MD, MBA, PhD, MSc, MPH, RAC, CPA.

Tools You’ll Use

• Microsoft 365 (Teams, Outlook, Copilot).
• Proficiency with AI tools.
• Comfortable adopting and learning new technologies.

Compensation & Benefits

• Competitive compensation in the range of $150,000 and up, plus performance-based bonus.
• 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.
• 401(k) match.
• Flexible vacation.
• Assistance for work-related certifications and training.
• Trail-blazing best-in-class clientele.

What It’s Like to Work at Gardner Law

• Rewarding.
• Great work-life balance.
• Variety in work and clientele.
• Collaborative.
• Flexible.
• Independent.
• Fast-paced.
• Impactful.
• Focused on FDA-regulated industry.
• Employee growth-oriented.
• Opportunity for growth and advancement.

How to Apply

Send your resume and cover letter to Tracy Erickson at terickson@gardner.law, and submit an application on LinkedIn.

About Gardner Law

Gardner Law is an FDA & Health law firm focused on regulatory, compliance, privacy, litigation, and commercial matters for clients in FDA-regulated and health industries. Our purpose, improving health and enhancing lives, guides our work with clients and our investment in our people.

Please send a resume and cover letter to Tracy Erickson at terickson@gardner.law with the subject line "Litigation Attorney Applicant," and submit an application on LinkedIn.

The Opportunity

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 Are 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

• Microsoft 365 (Teams, Outlook, Copilot).
• Clio, Adobe & AI-enabled tools.
• Legal research and e-discovery platforms.

Compensation & Benefits

• Competitive compensation $170,000 or more, commensurate with experience.
• Performance-based bonus opportunities.
• Flexible work environment (hybrid/remote).
• Opportunity to work with trailblazing, best-in-class FDA-regulated clients.
• Strong mentoring and coaching culture.
• Commitment to work-life balance, health, and well-being.
• Medical, HSA, disability, and life insurance.
• 401(k) with employer match.
• Open PTO policy.
• Tuition assistance for work-related certifications and training.

What It’s Like to Work at Gardner Law

• Rewarding
• Great work-life balance
• Variety in work and clientele
• Collaborative
• Flexible and independent
• Fast-paced and impactful
• Focused on FDA-regulated industries
• Employee growth-oriented
• Opportunity for advancement

How to Apply

Send your resume and cover letter to Tracy Erickson at terickson@gardner.law.

About Gardner Law

Gardner Law is an FDA & Health law firm focused on regulatory, compliance, privacy, litigation, and commercial matters for clients in FDA-regulated and health industries. Our purpose, improving health and enhancing lives, guides our work with clients and our investment in our people. The Litigation Practice Leader will have a meaningful opportunity to shape and grow an important component of the firm’s long-term strategy.

Please send a resume and cover letter to Tracy Erickson at terickson@gardner.law with the subject line "Food Attorney Applicant," and submit an application on Linkedin.