Sr. Regulatory Affairs Specialist, Taipei
SIEMENSTaipeiUpdate time: November 29,2022
Job Description
Do you want to join us in helping to fight 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 opportunities to go beyond your comfort zone in order to grow personally and professionally. Responsibilities: • Pursue the health authorities’approvals actively to market new products submitted to the local MOHW where applicable. Provide required regulatory support for existing products to ensure the timely renewal of the marketing authorization certificates. Timely and efficient filing of product registration dossiers or applicable documents at the Ministry of Health and Welfare. • Coordinate/Communicate with Siemens Healthcare Headquarters/Business lines to request and collect information required for registration. • Maintain close communication network with sales, marketing, service, logistic, finance to update regulatory issues, changes and the possible impact on business. • Plan regulatory strategy in advance in case of change in regulatory requirement. • Ensure timely and qualified handling of product complaints and related issues. • Prepare monthly status report on registration cases. • Other duties assigned from the line manager. Requirements: 1. At least 2 years quality or regulatory affairs experience in diagnostics, medical devices, or healthcare industry 2. Good oral and written communication skill in English 3. Excellent problem-solving, organizational, analytical, and critical thinking skill 4. Be able to develop and maintain working relationships, work successfully with colleagues and as an individual contributor Our global team: We are a team of 66,000 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. 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. As an equal opportunity employer, we welcome applications from individuals with disabilities. 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. Organization: Siemens Healthineers Company: Siemens Healthcare Limited Experience Level: Experienced Professional Full / Part time: Full-time

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