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 opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as a Senior Regulatory Affairs Specialist. 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. 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 invivo 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. Check our Careers Site at https://www.siemenshealthineers.com/enus/careers. This is a role well suited to an ambitious professional, looking for the next step in their career. As a Senior Regulatory Affairs Specialist, you will be responsible for: Developing and executing regulatory strategies for assigned projects to successfully register IVDs in U.S., EU, Canada, Japan, China and worldwide. Serving as the Regulatory Affairs representative on product core teams to ensure the assays developed are high quality and have been tested according to worldwide regulatory requirements. Reviewing technical plans and reports to ensure data accuracy, traceability and compliance to standards (e.g. ISO, CLSI). Reviewing and approving product labeling, advertising/promotional material, verification plans and reports. Participating in internal and external audits (as auditee and audit support). Reviewing new regulations or guidance documents and assessing their impact to the business. Developing new procedures or enhancing existing processes to facilitate efficient and effective business practices. Companion Diagnostics and Pharma /Biopharmaceutical experience a plus Required skills to have for the success of this role BS in Science, Engineering or related discipline MS in Science, Engineering or related discipline preferred 3-10 years regulatory affairs experience with FDA and EU regulations ( or equivalent ) Experience with immunoassays Experience in assay development or in a technical role in manufacturing Good technical writing skills Proficiency in reading, interpreting and summarizing technical reports Clear communication skills (both written and oral) and strong presentation skills, with a firm grasp of target audiences Creative and adept at problem solving 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 (including macros and Excel functions) Demonstrated ability to complete assignments independently and in teams Experience building consensus, presenting convincing arguments and overcoming objections Strong scientific background and understanding how changes could impact assay performance. Intercultural sensitivity Participation in industry groups and standard development committees preferred 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. Accommodations may be requested for certain medical or religious reasons. If you choose to submit an accommodation request it should be submitted within 3 business days of receiving a verbal offer. Details on how to submit approval will be provided by your recruiter. An accommodation approval must be confirmed prior to your start date. A start date cannot be confirmed until the accommodation has been reviewed. An accommodation is based on your role. If you are a currently a Siemens Healthineers employee with an existing approved accommodation, it will need to be re-evaluated prior to starting a new role. 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. Organization: Siemens Healthineers Company: Siemens Healthcare Diagnostics Inc. Experience Level: Mid-level Professional Full / Part time: 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. 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