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
Assistant General Counsel, Regulatory
Cardinal Health
Waukegan, IL
MGR POST MARKET STUDIES - 14000001LK
Abbott
Santa Ana, CA
Senior Financial Analyst - Growing Manager Care Health Org
Fallon Community Health Plan
Worcester, MA
Sr Manager, Business Conduct
Gilead Sciences
Foster City, CA
Chief Executive Officer
UCare Minnesota
Minneapolis, MN