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 Regulatory Affairs Manager. 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 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. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers. Key Responsibilities: Managing a team of regulatory affairs professionals responsible for planning and preparing regulatory submissions for in vitro diagnostic (IVD) medical devices into worldwide markets. Managing submission activities for a variety of IVD regulatory applications including EU IVDR Technical Files, US 510(k) premarket notifications, pre-submissions, export certificates, annual laser reports, and maintaining establishment registrations and device listings. Interacting closely with International Regulatory colleagues to prepare dossiers in accordance with country registration requirements. Ensuring that new or revised country specific requirements necessary for submissions are properly identified, analyzed and communicated to the affected organizations. May act as regulatory team lead in new product development teams to provide regulatory strategies and expertise to achieve market clearance/approval in the US, EU and International markets. Providing regulatory assessments for product design changes and is responsible for communicating product change notifications to in-country regulatory teams for implementation. Responsible for the development and training of staff to meet Quality/Regulatory requirements and department processes. Reviewing and approving labeling, advertising and promotional material to ensure compliance with processes and is consistent with cleared/approved product claims. May interact directly with governmental regulatory authorities (ex. FDA and Notified Bodies) during product submissions and inspections. May participate in Notified Body ISO audits and FDA inspections. Support internal quality audits. Required Education, Experience & Skills: BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Minimum of 5-8 years of experience in Regulatory Affairs, preferably with a global manufacturer of IVD medical devices, and with at least 2-5 years of experience managing or leading a team of staff. Must have demonstrated success with 510(k) and/or PMA, or other complex regulatory submissions. Must have experience interacting with FDA, Notified Bodies or other regulatory agencies. Must have strong knowledge of compliance with key international standards i.e. ISO 13485, FDA QSR, EU IVDR/MDR and a working knowledge of regulatory requirements worldwide. Must have strong leadership, written and verbal communication skills. Successfully passed Regulatory Affairs Certification (RAC), a plus. 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. As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. #LI-EM1 Organization: Siemens Healthineers Company: Siemens Healthcare Diagnostics Inc. Experience Level: Mid-level Professional Job Type: Full-time Equal Employment Opportunity Statement Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. 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