1.1 Quality Management
1.1.1 Implement and maintain the Company’s QMS in accordance to International Quality and Corporate Standards, and ensure compliance with legal or corporate specifications.
1.1.2 Ensure that corrective / preventive action plans are executed and completed in a timely manner, and the management is appraised of significant quality issues and progress.
1.1.3 Report any issues / complaints to the factory and support the factory to investigate and close out the issues in a timely manner.
1.1.4 Conduct periodic internal audits to ensure the QMS is effectively implemented and maintained.
1.1.5 Assume full responsibility as a Management Representative (including but not limited to participating in management reviews, promotion of awareness of quality and regulatory, continuous improvement of QMS and hosting 3rd party audits.)
1.1.6 Work closely with stakeholders to ensure that all Standard Operating Procedures (SOPs) are updated on a timely manner and are aligned with Global SOPs.
1.1.7 Work closely and communicate regularly with the factory Quality and Regulatory department to ensure no interruption of business due to Quality/Regulatory Affairs Issues.
1.1.8 Ensure that all controlled documents are maintained, revised and distributed according to Control of Document and Records procedure.
1.2 Regulatory Affairs
1.2.1 Coordinate all registration activities (including new product registrations and renewals) of Dornier products in Asia/Australia regions to ensure business continuity without any interruption of business
1.2.2 Monitor and initiate the extension for product registration in all sales regions.
1.2.3 Provide regulatory inputs to International Regulatory Affairs team for R&D projects and new business initiatives.
1.2.4 Support on enquiries and tenders that require certificates and/or documentation related to Regulatory Affairs regionally.
1.2.5 Produce periodic regulatory status updates to the management.
1.2.6 Ensure compliance with NEA, WSH and IMDA regulations for all Dornier products and employees.
1.3 Medical Device Reporting Officer (MDRO)
1.3.1 Handle incidents arising from all sales regions for the products and also support regional requirements based on product roadmap.
1.3.2 Coordinate the necessary measures and fulfil the obligation to report within the stipulated time frame to DMT’s MDRO and directly to all affected Asia/Australia authorities.
1.3.3 Support DMT’s MDRO by gathering information needed for the analysis and assessment of the reported incident.