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Attorney - Compliance

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

Reports to: Partner

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%)

Date posted: October 28, 2025

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 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 Qualifications:

  • Advanced degrees or certifications (e.g., MD, MBA, MPH, RAC, CIPP, CPA)
  • Comfort using Microsoft 365 and AI-enabled tools; adaptable to new technologies.
  • Knowledge of privacy laws and regulations (e.g., HIPAA, HITECH, GDPR, CCPA, and FTC).

Primary Functions:

  • 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.

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 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 fill out an application on LinkedIn and send 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%)

Date posted: October 30, 2024

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 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 - Privacy

Please fill out an application on LinkedIn and send 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-level

Exempt Status: Exempt

Hours of Work: Varies

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

Date posted: October 28, 2025

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.
  • 3+ 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.

Preferred 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.