IVD Support Engineers

Overview Engineer for Sysmex products for local market (SG). Responsible for all preventive and corrective support functions necessary to ensure high level of customer satisfaction with Sysmex’s range of products. Responsibilities Planning of corrective and preventive action visits for Sysmex’s Singapore customers Provide technical support to local (SG)...

**Responsibilities**: 1. Manage the daily operation and customer support to improve market share and profitability for the business. 2. Assist the managing director and coordinate with China and Thailand management. Provide regular reports/information to the management team on market / customer /sales movements; Ensure accurate tracking and reporting of all...

**_The Position _** - _Technical product specialist for specific models of products for AP region as well as support local market (SG). _ - _He shall function as 2nd level support for both the AP region and local market and also primary trainer and management for products of responsibility, i.e. Hematology, clinical Flow Cytometry, Hemostasis, Immunology,...

Job DescriptionMaintain and improve the Quality Management System (QMS) in line with ISO 13485, GDPMDS, and other relevant standards.Ensure compliance with HSA regulations and other international requirements (e.g. EU IVDR, FDA QSR).Prepare and manage regulatory submissions and product registrations for medical devices and IVD products.Handle post-market...

Maintain and improve the Quality Management System (QMS) in line with ISO 13485, GDPMDS, and other relevant standards.Ensure compliance with HSA regulations and other international requirements (e.g. EU IVDR, FDA QSR).Prepare and manage regulatory submissions and product registrations for medical devices and IVD products.Handle post-market...

Maintain and improve the Quality Management System (QMS) in line with ISO 13485, GDPMDS, and other relevant standards.Ensure compliance with HSA regulations and other international requirements (e.g. EU IVDR, FDA QSR).Prepare and manage regulatory submissions and product registrations for medical devices and IVD products.Handle post-market...

Support and develop regulatory submission plan for the region in collaboration with project team, manufacturing sites, supply chain, marketing and country manager Work closely with relevant manufacturing sites and other functions to obtain all the necessary documents to support product registration, renewal or amendment to existing product...

Responsibilities Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, GDPMDS, and other applicable regulations. Ensure compliance with local and international regulatory requirements, including HSA (Health Sciences Authority) regulations for IVD devices in Singapore. Manage documentation processes, including...

We are seeking an experienced Bioinformatics Scientist to support new diagnostics product development and support data analytics in software development for Software as a Medical Devices. In this role, you will play a crucial role in driving the successful execution of diagnostic products in collaboration with external partners. The ideal candidate should...

Develop and implement regulatory strategies to secure product approvals more quickly than competitors. - Lead complex decision-making processes among stakeholders and senior leadership in a dynamic regulatory environment. - Provide expert advice on regulatory strategy, Health Authority engagement, and submission activities for the IVD product lines. -...