Regulatory Focus™ > News Articles > Leader Sought for FDA's Influential Office of Device Evaluation

Leader Sought for FDA's Influential Office of Device Evaluation

Posted 16 March 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


Categories: Regulatory News

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