rf-fullcolor.png

 

March 16, 2015
by Alexander Gaffney, RAC

Leader Sought for FDA's Influential Office of Device Evaluation

The US Food and Drug Administration (FDA) is seeking a permanent leader for its medical device-focused Office of Device Evaluation (ODE), the division responsible for reviewing nearly all medical devices marketed in the US.

The office was most recently run by Christy Foreman, who stepped down in September 2014 to take a new role within FDA's new Center for Tobacco Products.

Bill Maisel, deputy director for science and chief scientist at FDA's Center for Devices and Radiological Health (CDRH), has been serving as acting director as the agency searches for a new director.

That search is now underway, according to a new job announcement posted by the federal government. CDRH says it is seeking candidates for ODE director, which it refers to as a "key leadership role."

"This is a high profile opportunity to be a top executive responsible for evaluating premarket submissions from the medical device industry and determining whether they should go to market," CDRH wrote in a job posting on the New England Journal of Medicine's website.

The ideal candidate will have executive-level management experience, strong knowledge of medical device development and regulation and a background in science, medicine or healthcare.

The posting notes that the office oversees more than 500 employees, and is responsible for the premarket review of nearly all medical devices in the US.

 

ODE Director – Job Posting

×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.