Careers

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.

The staff of Hyman, Phelps & McNamara, P.C., is a diverse and dedicated team who work together to provide outstanding support to the firm’s clients. We offer a collegial work environment where employees’ efforts are recognized and valued.