The Washington, D.C. office 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, engineering, health, or biotechnology background is preferred but also not required. Candidates must be admitted to the District of Columbia Bar.
Successful candidates will have outstanding writing and analytical skills, strong academic credentials, and a commitment to excellence. They will be thoughtful and practical problem solvers with excellent judgment, strong communication skills, and the ability to convey complex regulatory concepts clearly and effectively. We value associates who are highly responsive, client-focused, and able to work both independently and collaboratively as part of a team. Intellectual curiosity, a willingness to take initiative and "figure it out," a strong work ethic, and a positive, team-oriented attitude are essential. The role also offers significant opportunities to develop meaningful client relationships and to grow within a collaborative and market-leading practice.
The expected base salary range for this role is $235,000 to $310,000 per year. This range reflects a good-faith estimate of pay at the time of posting; the actual compensation offered may vary depending on factors such as the candidate's qualifications. This position is eligible for additional forms of compensation, which may include annual performance bonuses and discretionary bonuses. Employees in this role are also eligible for benefits offered by the firm, subject to applicable plan terms and conditions, which currently include medical, dental, and vision insurance; a 401(k) retirement plan; and paid time off. Additional benefits may include relocation. Please review this link for more information regarding employee benefits in the United States.
We will consider for employment qualified applicants with arrest and conviction records in a manner consistent with the requirements of applicable law, including the San Francisco Fair Chance Ordinance and City of Los Angeles Fair Chance Initiative for Hiring Ordinance.
A resume or CV is a must for our application system. We also encourage you to include a cover letter to tell us why you are interested in this position and a law school transcript (or the equivalent). Candidates applying for this position must have a law degree from an ABA-accredited law school and be admitted to the District of Columbia Bar or eligible to waive into the Bar.
To apply please complete the on-line application, attaching a resume and law school transcript.
All search firm submissions should be sent to the attention of Suzanne Hudgens at Submissions must include a resume and law school transcript.
This job description sets forth the responsibilities of this position and may be changed from time to time as shall be determined.
