Medical Device and Technology - Junior to Mid-Level Associate

Overview 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 with colleagues worldwide to help clients navigate complex and evolving regulatory frameworks. Responsibilities Provide strategic guidance on FDA regulatory pathways for medical devices. Support the preparation and submission of premarket applications, including 510(k) notifications, Investigational Device Exemptions (IDEs), De Novo classification requests, and Premarket Approval Applications (PMAs). Assist clients in navigating FDA review processes, including responding to deficiency letters and other agency inquiries. Work on post‑market compliance matters: quality system regulation issues, recalls and field corrective actions, adverse event reporting, vigilance obligations, and broader FDA enforcement and compliance strategies. Help clients develop practical, forward‑looking strategies for bringing innovative technologies to market while managing regulatory risk in a dynamic environment. Engage with emerging AI‑enabled medical device and digital health regulatory issues, such as algorithm change management, real‑world data and evidence, cybersecurity, and intersections with state, federal, and international frameworks. Qualifications Demonstrated interest in FDA regulatory law and medical device issues; experience with FDA medical device matters strongly preferred. Researching and analyzing regulatory questions, advising on regulatory pathways, or supporting the preparation of submissions and responses to the FDA. Preferred: prior experience at the FDA or within the medical device, pharmaceutical, or biotechnology industries. Preferred: scientific, engineering, health, or biotechnology background. Admitted to the District of Columbia Bar (or eligible to waive into the Bar). Outstanding writing and analytical skills, strong academic credentials, and a commitment to excellence. Thoughtful, practical problem solver with excellent judgment, strong communication skills, and the ability to convey complex regulatory concepts clearly. Highly responsive, client‑focused, independent and collaborative team player with intellectual curiosity, initiative, strong work ethic, and a positive team‑oriented attitude. Compensation and Benefits Expected base salary range: $235,000 to $310,000 per year. Eligible for additional compensation including annual performance bonuses and discretionary bonuses. Benefits: medical, dental, and vision insurance; 401(k) retirement plan; paid time off; relocation assistance (may be available). Equal Opportunity Hogan Lovells is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, age, national origin, disability, sexual orientation, gender identity or expression, marital status, genetic information, protected Veteran status or other factors protected by law. Hogan Lovells complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. #J-18808-Ljbffr Hogan Lovells