Associate Description:

Manatt, Phelps & Phillips, LLP is seeking a highly qualified associate with two to three years of experience to join our nationally recognized healthcare regulatory practice to work on medical device regulatory matters in our San Francisco, New York, or Washington, DC office.

Ideal candidates will have experience researching FDA medical device regulatory issues; providing advice on regulatory pathways; drafting regulatory submissions such as 510(k) Notices, Investigational Device Exemptions (IDEs), De Novo Requests and Premarket Approval Applications (PMAs); preparing responses to FDA premarket review; and posting market compliance questions and deficiencies. Scientific, health or biotech background is preferred. Experience at FDA is a plus.

Consultant/Manager Description:

Manatt Health is seeking a highly qualified consultant or manager with relevant expertise to work on medical device regulatory matters in our San Francisco, New York, or Washington, DC office. This is an exciting opportunity to be part of a nationally recognized healthcare strategy consulting team and work with clients who are passionate about improving healthcare.

Ideal candidates will have a deep understanding of the U.S. Food and Drug Administration’s (FDA’s) medical device regulatory issues as well as demonstrated ability to successfully navigate the FDA’s complex submission and review process, and experience guiding clients through the FDA approval process. Experience with FDA policies and requirements, product development and submissions processes, regulatory submissions such as 510(k) Notices, Investigational Device Exemptions (IDEs), De Novo Requests and Premarket Approval Applications (PMAs); FDA premarket review responses, FDA jurisdictional and postmarket compliance issues, advertising and promotion compliance, and clinical trial guidance is preferred. Candidates will be able to apply extensive regulatory expertise to determine the best approach to help clients achieve successful results, including identifying potential issues and regulatory risks