Job Description

Do you want to join us in helping to fight the world\'s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. We offer you a flexible and dynamic environment with opportunity to go beyond your comfort zone in order to grow personally and professionally. Sounds interesting? Then come in and join our ASEAN team as Quality & Regulatory Officer to analyze the requirements and prepares product related regulatory submissions. Your tasks and responsibilities: You will manage and maintain the Product registration and license database \xe2\x80\x93 timely submission of new product registration and amendment of approved products to obtain approval in shortest time. This will include compiling and submission and handling of additional request through the HSA online portal. You will handle post-marketing requirements for Medical Devices and ensuring the requirement are met. This includes Adverse Event reporting and Field Safety Corrective Actions where required. Handling of reportable field corrective action with HSA online tools and with Business Lines on FSA (Field Safety Action). You will handle update of process for Quality and EHS management system. Requesting for SOPs to be reviewed and reviewing SOPs as needed according to process. This will include liaising with the various process owners and handling of internal and external audits (including BPs) and follow-up of CAPAs. Update of Site Master File. You will provide Regulatory training to Sales, Marketing, Logistics new hires. You will manage the yearly application of Control Drug import licenses required for the business and work with Logistics to submit yearly report of all controlled drug and psychotropic substances stocks during end December. You will manage the dosimeter exposure and communicate with the Customer Service Engineers and Application Specialist if there is unusually high exposure besides monitoring certain EHS KPI. You will handle the Cority tool for safety incident investigation and liaising with the reporting party. To find out more about the specific business, have a look at https://www.siemens-healthineers.com/ Your qualifications and experiences: You hold a successfully completed Diploma or Degree in any science discipline. You have at least 2 years of relevant experience preferably in regulatory affairs. A qualified auditor would be an advantage. It will also be an advantage if you possess some knowledge in the post-market requirements including FSCA. Experience GDPMDS (Good Distribution Practice for Medical Devices) requirements and Quality management system is needed. You are able to work independently and meticulously with minimum supervision. Working Location: Singapore Our global team: We are a team of 68,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what\xe2\x80\x99s possible in healthcare to help improve people\xe2\x80\x99s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what\xe2\x80\x99s possible, to improve people\xe2\x80\x99s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started. To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes. Organization: Siemens Healthineers Company: Siemens Healthcare Pte. Ltd. Experience Level: Early Professional Full / Part time: Full-time