Gardner Law · 1 week ago
Regulatory Attorney
Twin Cities Area
Full-time
Hybrid
Entry, Mid Level
$150K/yr - $225K/yr
2+ years expGardner Law is an FDA law firm that specializes in regulatory, compliance, privacy, litigation, and commercial matters. They are seeking a Regulatory Attorney to lead projects related to FDA compliance, review promotional materials, and advise clients on regulatory submissions.
Responsibilities
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)
Qualification
Required
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
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))
Knowledge of HIPAA, HITECH, GDPR, CCPA, and FTC privacy frameworks
Advanced degrees, licenses, certifications favored, e.g., MD, MBA, PhD, MSc, MPH, RAC, CPA
Benefits
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.
Bonus program.
401(k) match.
Open vacation.
Tuition assistance for work-related certifications and training.
Company
Gardner Law
Gardner Law is an FDA law firm specializing in regulatory, compliance, privacy, commercial transaction, and litigation matters.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Tracy Erickson MAcc, C.P.A. (inactive)
Chief Financial Officer & Chief Operating Officer
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