Hyman Phelps and McNamara
Hyman, Phelps & McNamara, P.C., offers a cutting edge legal practice, excellent quality of life for its employees, and competitive salary and benefits packages. The firm environment is characterized by mutual respect, open channels of communication, and employee loyalty.

HPM is an equal opportunity employer.

Join Our Legal Team: Senior Medical Device Regulation Expert

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
Anne K. Walsh, at awalsh@hpm.com

Join Our Support Team

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.

All applicants must have excellent communication skills and the ability to work in a fast-paced atmosphere.

Click to see our current staff openings.