Regulatory Affairs Assistant

Defines and documents quality management system.
Implements quality management system throughout the organization
maintains, and continually improves the effectiveness of the quality system
Manage validation program
Manage calibration program
Conducts employe e cGMP/ISO and GLP training
Maintains and controls quality documents and quality records (i.e., procedures, DHRs, etc.)
Coordinates corrective and preventive action process
Ensures compliance with ISO and Applicable regulatory requirements and Council of European Communities Regulations for medical devices
Manages customer complaint/feedback system
Maintains internal and external quality audit records
Final product disposition
Quality control function in lab and sterilization area
Verification and validation of manufacturing processes
Coordinates & Conducting awareness of applicable regulatory and quality management requirement throughout the organization
Defining the sequence and interaction between processes
Conducting management review meeting
Reporting the performance of a quality system to management for review and provide information for improvement.