The Opportunity

ThisSenior Regulatory Affairs Specialistwill work out of our Pleasanton, CA location in theHeart FailureDivision. As an individual contributorinthe function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department.With limitedsupervisionyou will execute tasks and partner across business functions.

As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities.

WhatYou’llWork On
• As the Experienced professional in the Regulatory Affairs Sub-Function,possesseswell developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Interacts withFDA and otherregulatory agency toexpediteapproval of pending registration.
• Serves asregulatoryliaison throughout product lifecycle.
•Participatesin some of the followin...