Attorney - Regulatory

Job Overview

A law firm seeks a mid-level Attorney - Regulatory in Stillwater, MN. The role involves working with FDA-regulated industries, focusing on compliance, privacy, and litigation matters. The position requires minimal travel and offers a flexible work environment.

Duties

• Conduct anti-fraud and FDA compliance reviews of promotional materials.
• Draft opinions on compliance with laws such as FDCA, AKS, FCA, and PPSA.
• Participate in FDA meetings and make regulatory submissions.
• Perform legal research and advise clients on healthcare professional interactions.
• Serve on promotional and scientific material review teams.

Requirements

• 2+ years of experience in a medical device, pharmaceutical, or related industry.
• Ability to lead projects and manage multiple responsibilities.
• Strong attention to detail and effective communication skills.
• Ability to work with diverse viewpoints and personalities.
• Licensed to practice law in a U.S. state.

Education

• Bachelor of Arts or Bachelor of Science.
• Juris Doctor from an ABA-approved law school.

Certifications

• Unrestricted license to practice law in a U.S. state.
• Admission to any federal district court preferred.

Skills

• Proficiency with Microsoft 365 and AI tools.
• Knowledge of HIPAA, HITECH, GDPR, CCPA, and FTC privacy framework.
• Experience with FDA regulatory matters and medical device submissions.

Benefits

• Flexible work environment.
• Mentoring and coaching opportunities.
• Commitment to work-life balance and well-being.
• Medical, disability, and life insurance benefits.
• 401(k) match and open vacation policy.
• Tuition assistance for certifications and training.

This boutique law firm provides exclusive legal counsel to FDA-regulated companies in medical technology, biotechnology, and pharmaceutical industries. Its practice areas include compliance, ad promo review, sunshine reporting, regulatory, quality, enforcement, clinical, and privacy. Its team of attorneys has decades of experience in these areas. The firm's office is located in Stillwater, Minnesota.