Medical Device and Technology - Junior to Mid-Level Associate

The Washington, D.C. office of Hogan Lovells US LLP is seeking a junior to mid-level associate to join the Medical Devices group within our Food, Drug, Medical Device and Agriculture practice. This role offers the opportunity to work at the forefront of medical device regulation, advising clients across a broad spectrum of premarket and post-market compliance, enforcement, and strategic regulatory matters. Our Medical Devices practice operates on a truly global platform, coordinating seamlessly with colleagues across major markets worldwide to help clients navigate complex and evolving regulatory frameworks. In the United States, we have been advising companies on FDA regulatory matters for decades, including helping bring innovative and first-of-their-kind medical technologies to market since the Medical Device Amendments of 1976. Our team regularly works on cutting-edge issues involving software as a medical device (SaMD), artificial intelligence and machine learning-enabled technologies, digital health platforms, and novel diagnostic tools, alongside more traditional device and in vitro diagnostic products. The associate will play an integral role in advising clients on the full lifecycle of medical device regulation. 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. The associate will also work on post-market compliance matters, including quality system regulation issues, recalls and field corrective actions, adverse event reporting and vigilance obligations, and broader FDA enforcement and compliance strategies. 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. The role will involve helping clients develop practical, forward-looking strategies for bringing innovative technologies to market while managing regulatory risk in a dynamic environment. We are seeking candidates with a demonstrated interest in FDA regulatory law and medical device issues, and experience with FDA medical device matters is strongly preferred. This may include researching and analyzing regulatory questions, advising on regulatory pathways, or supporting the preparation of submissions and responses to the FDA. Prior experience at the FDA or within the medical device, pharmaceutical, or biotechnology industries is a plus, but is not required. A scientific, e