Medical Device & FDA Regulatory Associate — Washington, DC

A Washington, D.C. office is seeking a junior to mid-level associate to join the Medical Devices group within a broader Food, Drug, Medical Device and Agriculture practice. The role sits at the forefront of medical device regulation, advising clients on premarket and post-market compliance, enforcement, and strategic regulatory matters.

The practice operates on a global platform, coordinating with colleagues across major markets. In the U.S., the team has advised on FDA regulatory matters for decades and regularly handles cutting-edge issues such as software as a medical device (SaMD), AI/ML-enabled technologies, digital health platforms, and novel diagnostic tools, alongside traditional device and IVD products.

The associate will advise on the full lifecycle of medical device regulation: strategic guidance on FDA regulatory pathways; preparation and submission of premarket applications (510(k)s, IDEs, De Novo requests, PMAs); navigating FDA review and responding to deficiency letters; and post-market matters including quality system regulation, recalls and field corrective actions, adverse event reporting, and FDA enforcement strategy.

There will also be exposure to evolving AI, digital health, algorithm change management, real-world data, and cybersecurity issues, helping clients bring innovative technologies to market while managing regulatory risk.

• Demonstrated interest in FDA regulatory law and medical device issues; experience with FDA medical device matters strongly preferred
• Research and analysis of regulatory questions, advising on regulatory pathways, and/or supporting submissions and FDA responses
• Prior FDA or medical device, pharmaceutical, or biotechnology industry experience a plus, but not required
• Scientific, engineering, health, or biotechnology background preferred, but not required
• Admitted to the District of Columbia Bar (or eligible to waive in)
• Outstanding writing and analytical skills, strong academic credentials, and practical problem-solving ability
• Excellent judgment, communication skills, and ability to convey complex regulatory concepts clearly
• Highly responsive, client-focused, and able to work independently and collaboratively