Medical Device Regulatory Expert — Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

Hyman, Phelps & McNamara, P.C., the nation’s premier law firm dedicated exclusively to FDA and healthcare regulatory law, is seeking an experienced Medical Device Regulatory Expert to join its multidisciplinary team. This is a unique opportunity for a seasoned regulatory professional to apply technical and strategic expertise in a sophisticated legal services setting, advising medical device clients on complex premarket and postmarket matters.

The Role

The Regulatory Expert will serve as a key technical resource to the firm’s attorneys and clients, providing regulatory strategy, preparing and managing FDA submissions, and advising on device lifecycle compliance. Core responsibilities include:

• Premarket submissions: Drafting and managing 510(k)s, De Novo requests, PMAs, and IDEs, including submission strategy, technical documentation, and FDA interactions.
• Postmarket compliance: Advising on MDRs, recalls, corrections and removals, and field safety corrective actions, and counseling clients through enforcement and compliance matters.
• Regulatory strategy and counseling: Guiding startups, manufacturers, and private equity clients on classification, predicate selection, regulatory pathways, and lifecycle planning.
• Cross-functional collaboration: Supporting the firm’s attorneys on enforcement actions, warning letter responses, advisory opinions, citizen petitions, and litigation matters.

Familiarity with in vitro diagnostics, software as a medical device (SaMD), cybersecurity, and AI/ML-enabled technologies is central to the role.

Key Qualifications

• Minimum five years’ experience in medical device regulatory affairs, including FDA premarket submissions and postmarket compliance.
• Bachelor’s degree in engineering, computer science, life sciences, biomedical engineering, or a related technical field.
• Substantive experience at or with FDA, a device manufacturer, a regulatory consultancy, or a law firm.
• Working knowledge of FDA’s device regulatory framework and applicable guidance.
• Excellent written and oral communication skills.

Preferred: an advanced degree (M.S., Ph.D., or equivalent); RAC certification from RAPS; experience with AI/ML-based SaMD submissions and in vitro diagnostics; and prior law firm, professional services, or consulting experience.

Compensation

The firm offers competitive compensation of $275,000-$325,000 annually, commensurate with experience and a comprehensive benefits package, including medical, dental, and vision insurance; a 401(k) with employer contribution; generous paid time off; and professional development support.

How to Apply

Interested candidates should submit a resume, cover letter, and writing sample to recruiting@hpm.com. References will be requested later in the process.

Hyman, Phelps & McNamara, P.C. is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.