- Ensure the Quality Management System (QMS) fully adheres to ISO 13485:2016 requirements across all processes, including product design, manufacturing, and distribution.
- Prepare and manage technical documentation for regulatory submissions in accordance with EU MDR 2017/745, ISO 13485:2016, and other applicable regulatory standards.
- Support facility project management activities, ensuring all related documentation and processes remain compliant.
- Lead or support audit preparation, including compilation and readiness of required documentation for internal and external audits.
- Participate in internal and external audits to demonstrate ongoing compliance with ISO 13485:2016.
- Collaborate with Quality Management and other departments to investigate nonconformities and implement effective Corrective and Preventive Actions (CAPA).
- Ensure regulatory risk assessment activities are properly documented and kept up to date.
- Evaluate and document the regulatory implications of any changes to product design, processes, or the QMS.
- Promote and maintain regulatory compliance awareness across all relevant departments
- Support and actively participate in the product registration process in accordance with CTD (Common Technical Document) and ACTD (ASEAN Common Technical Dossier) formats, as well as for Rest of World (ROW) markets.
Note: Deputation means - RA Executive is deputed and authorized to perform the RA Executive's roles in case of his absence.