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This position has the responsibility to manage and maintain the Quality Management System of the company regionally and for business units, requiring the individual to coordinate with official authorities, either directly or indirectly via distributors, on regulatory requirements and issues concerning Dornier medical devices.
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.
2.1 Frequent travel regionally to manage the requirements of the role and establish good working relations with regulatory authorities and consultants.
1. Education/Qualifications
2. Experience
3. Aptitude
4. Operational Skills
We regret that only shortlisted applicants will be notified.
This position is responsible for coordinating Quality and Regulatory activities with manufacturing sites for complaints resolution and closure and assisting in registration activities in Asia/Australia regions.
Education/Qualifications
Experience
Aptitude
Operational Skills
We regret that only shortlisted applicants will be notified.
The Service Manager is involved in organizing and executing initiatives that will grow the Service business and improve the key performance metrics of the Service organization.
Education/Qualifications
Experience
Aptitude
Operational Skills
We regret that only shortlisted applicants will be notified.
Support and assist the Group Consolidation team in all financial and management reporting on group consolidation accounts, including presentation of reports and statistics reflecting earnings, profit, cash balances and other financial results. Support in coordinating the budgeting and forecasting processes with SBUs and assist in the year-end statutory audit process. Assist and work closely with the accounting department to help maintain the accounting records and support the financial operations of Advanced MedTech Group of companies.
1.1 Coordinate Group consolidation and reporting of financial and management reporting as well as manage the year-end statutory audit process with external auditors. Work closely with the consolidation and reporting team on compliance and on the implementation of International Financial Reporting Standards and support the budgeting and forecasting processes.
1.2 Group Consolidation & legal entity accounting
1.2.1. Liaise with SBUs to ensure timely submission of monthly Cognos data and Management Information System (MIS) reporting to ensure no delay in group consolidation of financial and management reporting.
1.2.2. Handle Group consolidation for financial and management reporting and ensure accurate and timely submission of group reports to the Parent Company.
1.2.3. Handle legal entity full set of accounts and accounting-related activities including liaising with tax agents to provide information for corporate income tax return preparation as well as preparation of quarterly GST returns and filing.
1.3 Cognos Controller Reporting
1.3.1 Coordinate and verify monthly submission of Cognos reporting data and MIS reports from all SBUs to facilitate monthly management review process.
1.4 Budgeting and Forecasting process
1.4.1. Ensure that SBUs submit the budget and forecast reports on time to facilitate the review processes.
1.4.2. Involve in the preparation and consolidation of group budgets and forecasts including Profit & Loss, Balance Sheet, Cash Flow and variance analysis.
1.5 Year-end Statutory Audit
1.5.1 Coordinate and manage year-end statutory audit and work closely with SBUs to ensure timely completion and submission of audited financials and report schedules within the Parent Company’s stipulated deadline.
1.6 Support in pipeline and business review
1.6.1. Participate actively in regular sales pipeline and business reviews with sales and operating business units
2.1 Support the implementation of improvement projects in accounting, reporting and finance related activities.
2.1.1 Evaluate and implement improvement in operational processes
2.1.2. Support in Ad-hoc projects
Assists the Group Finance team in ad-hoc projects and assignments (e.g. annual corporate insurance renewal and treasury support on banking related matters)
We regret that only shortlisted applicants will be notified.