Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a Medical Device Regulation Expert to support our robust device practice. We are looking for someone to help our clients develop regulatory strategies and draft premarket submissions for their products. The ideal candidate has a science background, strong experience in medical device regulatory affairs, and specific experience preparing premarket submissions for medical devices and combination products, including:
• Premarket Notifications (“510(k)”); • Premarket Approval Applications (“PMA”); • Petitions for Evaluation of Automatic Class III Designation (“de novo”); • Humanitarian Use Designation (“HUD”) / Humanitarian Device Exemption (“HDE”) applications; • Investigational Device Exemption (“IDE”) applications;
Expertise in clinical study design, in vitro diagnostics, or statistical analysis is a bonus but not required. We also prefer individuals who have work experience within FDA’s Center for Devices and Radiological Health or interfacing with FDA as part of the premarket review process.
Compensation is competitive and commensurate with experience.
HP&M is an equal opportunity employer. Qualified candidates should send your resume to
Hyman, Phelps & McNamara, P.C. is the largest dedicated food and drug law firm in the country. Our niche practices in the areas of new drug development, controlled substances, advertising, and health care law complement our core FDA practice. Our knowledge of the laws and regulations governing drugs, medical devices, foods, dietary supplements, and cosmetics is unparalleled in breadth and depth.