Now’s our time to inspire the future of healthcare together. Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 60,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us. Join our team now at Siemens Healthineers as Regulatory Specialist 2. The RA Specialist Level 2 is a member of the TTN international RA team and is responsible for supporting international product registrations for Atellica Solutions and ADVIA Centaur products. Creates and implements strategies to support Siemens RU worldwide including Asia-Pacific, Middle East Asia, South and Latin America and Europe in registering Atellica Solutions and ADVIA Centaur products. Provides answers to technical questions from international regulatory authorities. Prepares and provides technical documents (test reports). Leads projects related to new product registrations, license renewals, and re-registration requests via TeamSpace. Liaises with RA core team and design change team members to support product registrations worldwide. Various interdepartmental communications with marketing, manufacturing, R&D, OEMs, labeling, and others to support an efficient and effective international product registration process. The position reports to the Sr. Manager, Regulatory Affairs. Responsibilities The RA Specialist Level 2 is a member of the TTN international RA team and is responsible for supporting international product registrations for Atellica Solutions and ADVIA Centaur products. Interacts with other international RA colleagues to establish best practices. Effective interdepartmental communications. Organizes and sends international regulatory submission dossiers. Creates and implements strategies to supports Siemens RU worldwide including Asia-Pacific, Middle East Asia, South and Latin America, and Europe. Provides answers to technical questions from international regulatory authorities. Prepares and provides technical documents (test reports). Leads projects related to new product registrations, license renewals, and re-registration requests using RAPID database. Liaises with RA core team and design change team members to support product registrations worldwide. Various interdepartmental communications with marketing, manufacturing, R&D, OEMs, labeling, and others to support an efficient and effective international product registration process. Required Knowledge/Skills, Education, and Experience Advanced degree 4+ years regulatory affairs experience. Knowledge and experience with global registrations of IVDs. Required amount of travel with the position o None or very minimal (<5%). Required knowledge, skills, or expertise Good technical writing skills Ability to read and interpret technical reports Knowledge of regulatory requirements worldwide Creative and adept at problem solving Effective communication skills Great focus with attention to detail Able to multi-task and work effectively in a dynamic environment Skilled in Outlook, Adobe Acrobat and Microsoft Office applications Able to work independently Preferred Knowledge/Skills, Education, and Experience College degree in a scientific discipline. Experience communicating with non-native English speakers Experience in laboratory environment (e.g., Med Tech background) Bi-lingual Experience with immunoassays Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date except where prohibited by state law. (Note: Accommodations may be requested for certain medical or religious reasons) At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally. If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers. If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about. As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. Organization: Siemens Healthineers Company: Siemens Healthcare Diagnostics Inc. Experience Level: Early Professional Job Type: Full-time Equal Employment Opportunity Statement Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law Applicants and employees are protected under Federal law from discrimination. To learn more, Click here. Pay Transparency Non-Discrimination Provision Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here. California Privacy Notice California residents have the right to receive additional notices about their personal information. To learn more, click here.