Description :
Primary Purpose
Re sponsible for the implementation and administration of organization activities to support and ensure regulatory compliance .
Reports to:
Vice President, Quality Assurance and Regulatory Affairs
Direct Reports:
0 - 5 Regulatory Affairs Coordinators
Primary Functions
Prepare 510(k) and International product submissions
Support inte rnational product registrations
Prepare and maintain product Technical Files
Manage organization?s external document control
Review regulatory incident reports
Interface with customers including ambulance service and hospital personnel in regard to incident reports
Manage device recall activities
Interface with FDA and other International Regulatory Agencies personnel (e.g. MDR, Recall Coordinator)
Identify corrective actions and process improvements
Represent Regulatory Affairs in multi-discipline product development teams
Ensure that all work activity is performed in accordance with established procedures and regulatory requirements
Prepare and maintain various documentation required by the FDA
Participate as an auditor in internal audit activities
Participate as the Regulatory Affairs representative in Engineering Change Order review meetings
Other duties as assigned
Competencies
Fo ur year college degree
Excellent oral and written communication skills
Excellent organization skills
6+ years related experience in a medical device regulatory capacity
Knowledge of FDA, European , Canadian and Japanese Regulatory Requirements