On-site - Quezon City; 3-5 yrs exp; Master; Full-time

Job Description

Responsibilities

• As a Regulatory Affairs Officer, you will be responsible for ensuring that our medical devices meet all necessary regulatory requirements and standards.
• Your key responsibilities will include product registration, compliance management, documentation and reporting, pharmacovigilance, communication and collaboration, and staying updated with regulatory changes. You will work closely with cross-functional teams to facilitate regulatory submissions and maintain compliance with FDA regulations.
• Product Registration
• Prepare and submit comprehensive registration dossiers for medical devices.
• Manage the renewal process for existing product registrations.
• Monitor the status of registration applications and address any queries from the FDA.
• Compliance Management
• Ensure adherence to all applicable r...