Associate — Medical Devices (Healthcare) — Washington, DC

Join a global medical devices team advising on FDA regulatory matters across the full product lifecycle. The role focuses on premarket and post-market compliance, enforcement, and strategic regulatory counseling for medical device, in vitro diagnostic, and digital health technologies.

The team works on cutting-edge issues including software as a medical device (SaMD), AI/ML-enabled tools, cybersecurity, real-world evidence, and novel diagnostics, coordinating with colleagues across major markets. The associate will support preparation and submission of premarket filings (e.g. 510(k), De Novo, IDE, PMA), respond to agency inquiries, and advise on post-market obligations such as quality systems, recalls, adverse event reporting, and enforcement strategy.

Ideal candidates have demonstrated interest in FDA regulatory law and medical device matters, strong writing and analytical skills, and the ability to communicate complex regulatory concepts clearly. The role offers client-facing opportunities and professional development within a collaborative, market-leading practice.

• Admission to the District of Columbia Bar (or eligibility to waive into the D.C. Bar)
• Experience or demonstrated interest in FDA medical device regulation; prior FDA, industry, or law firm experience preferred
• Scientific, engineering, health, or biotechnology background preferred but not required
• Excellent writing, analytical, and communication skills; ability to work independently and in teams