Ultrasound Quality & Regulatory Affairs Manager

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 Ultrasound (US) team as Ultrasound Quality & Regulatory Affairs Manager to analyze the requirements and prepares product related regulatory submissions. Your tasks and responsibilities: You will manage Ultrasound business medical device registration, including 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 be handling of NEA licenses required for the medical device through the online portal. You will support and coordinate new and modified device registration in ASEAN countries with local business partners. You will be handling of post-marketing requirements for medical devices and ensuring the requirement are met for the ASEAN business partners. This includes Adverse Event reporting and Field Safety Corrective Actions where required. Handling of reportable field corrective action with HSA on online tools and with the headquarter and local business partners. You will be establishing and maintaining quality process for Quality and EHS management system such as ISO 13485. This will include liaising with the various process owners including the headquarter. You will be handling external audits for all certification and licenses required for the business. You will be handling audits of business partners and service providers. You will be handling the required product licenses with the various Regulatory Bodies of the new products which also include the Wi-Fi, RFID licenses. You will keep abreast of all the new regulations and requirements especially those which impact Ultrasound business directly and communicate these requirements to the relevant stakeholders. To find out more about the specific business, have a look at https://www.siemens-healthineers.com/ultrasound Your qualifications and experiences: You hold a successfully completed Bachelor Degree in Science, Engineering, or medical related disciplines. You have at least 3 years of working experience in quality or regulatory department of medical device industry. Your attributes and skills: You possess knowledge in Singapore/ ASEAN medical device regulations, and relevant technical standards. Understanding of quality management system such as ISO 13485 or 9001 requirements. You are able to work independently and meticulously with minimum supervision. Rigorous work style, high sense of responsibility and strong team spirit, and the ability to work under strong pressure. Clear and effective communication both in verbal and writing English; other language would be a plus. 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’s possible in healthcare to help improve people’s 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’s possible, to improve people’s 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: Experienced Professional Full / Part time: Full-time