Job Description
Every day our products and services help to save lives
around the globe. Therefore, we make quality and
reliability our number one priority.
Get to know us and join our teamas
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...