Medical Device Regulatory Associate, Washington, DC · Magic Circle Firm

Global firm with decades of FDA regulatory expertise seeks associates to join the medical device and life sciences practice. Work on cutting-edge regulatory matters including compliance for software as medical device (SaMD), AI/ML-enabled technologies, digital health platforms, and novel diagnostics. You'll advise clients across the full lifecycle of medical device regulation in a practice that coordinates seamlessly across major markets worldwide.

The work:

• Advise on FDA regulatory pathways and compliance strategies
• Support preparation of premarket applications (510(k), IDE, De Novo, PMA)
• Navigate FDA review processes and respond to agency inquiries
• Handle post-market compliance including quality systems, recalls, and adverse event reporting
• Address emerging regulatory issues in AI-enabled and digital health technologies

What they're looking for:

• 1-6 years of experience
• Interest in FDA regulatory law and medical device matters
• Prior FDA experience or medical device/pharma/biotech industry background preferred
• Scientific, engineering, or health background preferred but not required
• District of Columbia Bar admission required
• Excellent writing, analytical, and communication skills