This includes providing strategic guidance on FDA regulatory pathways; supporting the preparation and submission of premarket applications, including 510(k) notifications, Investigational Device Exemptions (IDEs), De Novo classification requests, and Premarket Approval Applications (PMAs); and assisting clients in navigating FDA review processes, including responding to deficiency letters and other agency inquiries. In addition to traditional regulatory work, the associate will be exposed to the rapidly evolving legal and policy landscape governing AI-enabled medical devices and digital health solutions, including issues relating to algorithm change management, real-world data and evidence, cybersecurity, and the intersection of FDA requirements with emerging state, federal, and international regulatory frameworks.