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Compliance Attorney—FDA & Health Law

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

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

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

Essential qualifications:

  • 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

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

COMPENSATION & BENEFITS

  • Competitive compensation starting at $200,000+, 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, disability, and life insurance
  • 401(k) with employer match
  • Open vacation policy
  • Financial assistance for work-related certifications and training

WHAT IT IS 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 & Health industry
  • Employee growth-oriented
  • Opportunity for advancement

HOW TO APPLY

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

Litigation Attorney—FDA & Health Law

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.

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

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.

Food Attorney

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.

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

Industry: Food and beverage; FDA and USDA regulatory law

Employment Type: Full-time, exempt

Reports to: Managing Partner

Travel: As client matters require

The Opportunity

Gardner Law is seeking an experienced Food Attorney to advise food and beverage companies on regulatory, compliance, and commercial matters throughout the product life cycle.

The attorney will counsel manufacturers, distributors, farms, cooperatives, restaurant chains, and beverage companies on labeling, advertising, food safety, manufacturing, and recalls. This role calls for sound legal judgment, clear communication, and practical advice that helps clients make informed business decisions.

The Food Attorney will manage client matters independently and collaborate with colleagues across the firm’s regulatory, compliance, litigation, privacy, and commercial practices.

What You’ll Do

  • Advise food and beverage clients on FDA, USDA, FTC, and related state law requirements affecting product development, manufacturing, distribution, and retailing.
  • Review food labels, Nutrition Facts panels, packaging, websites, advertising, and health benefit claims for regulatory and consumer protection risk.
  • Counsel clients on food additives, ingredient status, petitions, and generally recognized as safe (GRAS) determinations.
  • Advise on food safety programs, quality requirements, inspections, and responses to agency inquiries and warning letters.
  • Guide clients through recalls, corrections, removals, and related communications with regulators and business partners.
  • Help clients assess and respond to FDA, USDA, FTC, and state and local enforcement matters, government investigations, and competitor complaints.
  • Work with litigation counsel on food labeling, consumer fraud, foodborne illness, and product liability disputes.
  • Conduct regulatory due diligence for transactions involving food and beverage businesses.
  • Build trusted client relationships, manage matters and budgets, and deliver timely, business-minded advice.
  • Contribute to client development through writing, presentations, industry engagement, and collaboration across practice areas.

What We’re Looking For

Essential qualifications:

  • Juris Doctor from an ABA-accredited law school.
  • Licensed and in good standing in at least one U.S. jurisdiction.
  • Experience advising food and beverage companies on FDA, USDA, and related regulatory matters in a law firm, government agency, or in-house legal department.
  • Working knowledge of food labeling; FDA, USDA, FTC, and state and local advertising and claims; food safety; and agency compliance and enforcement processes.
  • Ability to analyze complex regulatory questions and translate them into practical guidance for business and legal teams.
  • Strong legal writing, communication, project management, and client service skills.
  • Ability to manage multiple matters independently and collaborate with colleagues across disciplines.

Preferred qualifications:

  • Experience with food additive petitions, GRAS determinations, recalls, or agency investigations.
  • Experience advising on FTC advertising requirements, consumer protection claims, or food labeling litigation.
  • Established relationships in the food and beverage industry and an interest in business development.
  • Experience with regulated products beyond conventional food, such as dietary supplements or beverages.

Tools You’ll Use

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

Compensation & Benefits

  • Competitive compensation commensurate with experience.
  • Performance-based bonus opportunities.
  • Flexible work environment (hybrid/remote).
  • Opportunity to work with FDA-regulated clients across the food and beverage industry.
  • 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.
  • Flexible 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.

Attorney - Privacy

Please send a resume and cover letter to Tracy Erickson at terickson@gardner.law with the subject line "Privacy Attorney Applicant."

Reports to:  Managing Attorney

Industry: Law Practice (FDA-regulated industry)

Employment Type: Full-time

Location: Flexible (office located in greater Minneapolis/St. Paul area)

Licensure: Unrestricted license to practice law in a U.S. state

Preferred License: Admission to any federal district court

Level: Mid-Senior level

Exempt Status: Exempt

Hours of Work: Varies

Travel Required: Yes (minimal, e.g., <5%)
 

About Gardner Law:

 

Gardner Law is an FDA law firm that specializes in regulatory, compliance, privacy, litigation, and commercial matters. Improving health and enhancing lives is our purpose at Gardner Law and it guides everything we do.

Essential Qualifications:

 

  • 3+ years of experience working in industry at a medical device, pharmaceutical, biologic, or diagnostic company, e.g., working in Legal, Privacy, Compliance, Contract Management, Regulatory Affairs, Quality Affairs, Clinical Affairs, Product Management, R&D, or a related role.
  • 5+ years of experience in privacy, cybersecurity, compliance or related field, and knowledge of and experience applying privacy, cybersecurity, and AI laws and regulations in a health care setting (e.g., HIPAA, HITECH, GDPR, CCPA, CAN-SPAM, TCPA, COPPA, FTC, Colorado AI Act, EU AI Act, EU Data Act).
  • Demonstrated 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 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.

Primary Qualifications:

 

  • Advanced degrees, licenses, certifications are favored, e.g., MD, MBA, PhD, MSc, MPH, RAC, CPA.
  • 3+ years of experience working as either an in-house or law firm attorney.
  • Knowledge of health care laws and regulations (e.g., Federal Food, Drug and Cosmetic Act (FDCA), Anti-Kickback Statute (AKS), False Claims Act (FCA), and Physician Payments Sunshine Act (PPSA)).

Primary Functions:

 

  • Advising on compliance with privacy, AI, and cybersecurity requirements, including HIPAA, HITECH, FTC Act, GDPR, CCPA, CAN-SPAM, TCPA, Colorado AI Act, EU AI Act, EU Data Act and other laws.
  • Designing, drafting, implementing, and reviewing privacy policies and procedures.
  • Evaluating marketing programs, including websites and mobile applications for privacy compliance.
  • Reviewing medical product privacy considerations (data flow, consent and secondary use, business associate/HIPAA analysis, legal opinions on privacy matters).
  • Reviewing and negotiating business associate agreements, data processing agreements, privacy clauses, AI and data security clauses, standard contractual clauses, and other privacy and data-related or technology agreements.
  • Auditing privacy and cybersecurity programs including inquiries based on standards such as ISO 27001, NIST, and others.
  • Assisting manufacturers in building HIPAA and privacy compliance programs.
  • Performing privacy officer or data protection officer services on a contract basis.
  • Privacy training for organizations.
  • Drafting, reviewing, and evaluating contact forms, opt-in consents, authorizations, and privacy policies/notices.
  • Supporting routine privacy and security incident matters.

Benefits:

 

  • Flexible work environment.
  • Competitive compensation in the range of $165,000 and up, plus performance-based bonus.
  • 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.

Words our employees use to describe 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.

Attorney - Regulatory

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

Reports to: Managing Attorney

Industry: Law Practice (FDA-regulated industry)

Employment Type: Full-time

Location: Flexible (office located in greater Minneapolis/St. Paul area)

Licensure: Unrestricted license to practice law in a U.S. state

Preferred License: Admission to any federal district court

Level: Mid-level

Exempt Status: Exempt

Hours of Work: Varies

Travel Required: Yes (minimal, e.g., <5%)
 

About Gardner Law:

 

Gardner Law is an FDA law firm that specializes in regulatory, compliance, privacy, litigation, and commercial matters. Improving health and enhancing lives is our purpose at Gardner Law and it guides everything we do.

Essential Qualifications:

 

  • 2+ 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:

 

  • Knowledge of HIPAA, HITECH, GDPR, CCPA, and FTC privacy framework
  • Advanced degrees, licenses, certifications favored, e.g., MD, MBA, PhD, MSc, MPH, RAC, CPA.
  • 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)).

Primary Functions:

 

  • Anti-fraud and FDA compliance review of promotional materials and commercial programs.
  • Drafting opinions regarding compliance with various laws including: FDCA, AKS, FCA, PPSA, HIPAA, among others.
  • 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).

Tools:

 

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

Benefits:

 

  • Flexible work environment.
  • Competitive compensation in the range of $150,000 – $225,000, plus performance-based bonus
  • 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.

Words our employees use to describe 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.