5 ways to navigate the FDA regulatory process

11/4/2011 | MedCityNews.com

Companies seeking medical device approval can make the wrong turn by not communicating with regulators often or soon enough, not having a thorough plan prior to an FDA meeting or failing to have representation, said Tammy Carrea, vice president of quality and regulatory affairs at TransEnterix. Speaking at the medtech11 conference, Carrea suggested five ways to successfully steer medical devices through the FDA, including engaging regulatory staffers early and setting up a timetable and budget ahead of time.

View Full Article in:

MedCityNews.com

Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
Counsel – Regulatory Affairs
RAI Services Company
Winston Salem, NC
Director of Program Development
AdvaMed
Washington DC, DC
Director of System QA
LifeWatch Services, Inc.
Rosemont, IL
Director of Business Development and Membership
AdvaMed
Washington DC, DC
Director, Corporate Counsel
Regeneron
Tarrytown, NY