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. Position Overview 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. Responsibilities Advise clients on the full lifecycle of medical device regulation, including FDA regulatory pathways. Support the preparation and submission of premarket applications such as 510(k) notifications, IDEs, De Novo classification requests, and PMAs. Assist clients in navigating FDA review processes, responding to deficiency letters and other agency inquiries. Work on post‑market compliance matters: quality system regulation, recalls, field corrective actions, adverse event reporting and vigilance obligations, and broader FDA enforcement and compliance strategies. Expose clients to evolving legal and policy landscape for AI‑enabled medical devices and digital health solutions, addressing algorithm change management, real‑world data and evidence, cybersecurity, and intersection with emerging state, federal, and international regulatory frameworks. Develop practical, forward‑looking strategies for bringing innovative technologies to market while managing regulatory risk. Qualifications Demonstrated interest in FDA regulatory law and medical device issues; experience with FDA medical device matters strongly preferred. Experience 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. Must be admitted to the District of Columbia Bar (or eligible to waive into the Bar). Outstanding writing and analytical skills, strong academic credentials, commitment to excellence. Strong communication skills, ability to convey complex regulatory concepts clearly and effectively. Highly responsive, client‑focused, capable of independent and collaborative work. Intellectual curiosity, willingness to take initiative, strong work ethic, positive team‑oriented attitude. Compensation & Benefits Base salary range: $235,000 to $310,000 per year, with potential annual performance bonuses and discretionary bonuses. Eligible for benefits, including medical, dental, vision insurance, 401(k) retirement plan, and paid time off; relocation benefits may be available. For detailed benefits information, please refer to the firm’s benefits portal. Equal Opportunity Employment 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 provides reasonable accommodations. If an accommodation is needed for the application or interview process, contact our Benefits Department at View email address on click.appcast.io. #J-18808-Ljbffr Hogan Lovells