Regulatory Affairs Specialist (#13-9045) AccessClosure
THIS JOB HAS EXPIRED JOB DESCRIPTION (#13-9045)
TITLE: Regulatory Affairs Specialist FLSA: Exempt LOCATION: Mountain View POSTING DATE: 5/14/2013
Provide administrative and technical support to Regulatory Affairs management in order to remain in compliance with all FDA and other U.S. and international regulatory requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
Prepare portions of IDE, PMA and Design Dossier original submissions and subsequent revisions/supplements and amendments
May participate in project team meetings as a Regulatory representative
Coordinate regulatory submissions
Assist with preparation of presentations to FDA reviewers and/or inspectors as needed
Maintain a library of publications and articles
Maintain a well-organized and efficient filing system of all clinical and In-vivo trial records
Ensure compliance with FDA and European regulations and guidelines as well as relevant company SOP?s and protocols
Provide assistance with international product registrations and licensing requirements
Maintain information in various compliance databases and produce reports as needed
Bachelors? degree in related discipline and 2+ years related experience in health-care related industries (hospitals, labs, pharma, IVD or devices), experience in the medical device industry preferred.
Experience and involvement with MDRs, IDEs, PMAs and 510(k) filings a plus
An advanced degree is desirable. Interventional cardiology experience would be a plus.
Excellent written and oral communication skills; technical writing capabilities are a must.
A hands-on, decisive, action-oriented style must be evident.
No direct supervisory responsibilities.
||645 Clyde Avenue |
Mountain View, CA 94043
THIS JOB HAS EXPIRED