Every day our products and services help to save lives
around the globe. Therefore, we make quality and
reliability our number one priority.

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Job Function: Patient Health & Regulatory Affairs

Regulatory Affairs and Quality Assurance

• Ensure company operations comply with applicable regulatory requirements, including FDA Philippines regulations and other relevant government standards.
• Prepare, compile, and submit regulatory dossiers and applications (registrations, notifications, variations, and reports) to the FDA Philippines in accordance with regulatory timelines and company requirements.
• Manage post-market surveillance activities, including monitoring and reporting of complaints, adverse events, CAPA, FSCA, and product recalls until proper closure and documentation.
• Support and maintain the ISO 9001:2015 Quality Management System, including participation in Internal Qua...