Medical Device and Technology - Junior to Mid-Level Associate

The role

The Washington, D.C. office is seeking a junior to mid-level associate for the Medical Devices group within the Food, Drug, Medical Device and Agriculture practice. This role involves advising clients on the full lifecycle of medical device regulation, including premarket and post-market compliance, enforcement, and strategic regulatory matters, with a focus on cutting-edge issues like SaMD and AI-enabled technologies.

What you'll do

• Advise clients on the full lifecycle of medical device regulation
• Provide strategic guidance on FDA regulatory pathways
• Support the preparation and submission of premarket applications
• Assist clients in navigating FDA review processes
• Respond to deficiency letters and other agency inquiries
• Work on post-market compliance matters
• Assist with quality system regulation issues
• Assist with recalls and field corrective actions
• Assist with adverse event reporting and vigilance obligations
• Assist with broader FDA enforcement and compliance strategies
• Expose to the legal and policy landscape governing AI-enabled medical devices and digital health solutions
• Help clients develop practical, forward-looking strategies for bringing innovative technologies to market
• Help clients manage regulatory risk in a dynamic environment
• Research and analyze regulatory questions
• Advise on regulatory pathways
• Support the preparation of submissions and responses to the FDA
• Develop meaningful client relationships

What we're looking for

Benefits

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