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.