The Vice President, Regulatory Affairs, Clinical Affairs, and Post Market Regulatory Compliance is responsible for ensuring Regional Unit (United States and Canada) compliance to internal and external regulatory requirements and enabling Regional Unit commercial business objectives. He/She will manage a multi‐country team of regulatory and clinical affairs specialists who provide direct support to regionally and non‐regionally‐based Business Areas and Business Lines. This role has significant strategic impact across United States and Canadian business activities, ultimately resulting in a significant global Healthineers impact. Job Responsibilities Manages pre‐market regulatory and clinical commercialization activities including new and modified device and drug applications to FDA and Health Canada. This includes but not limited to clinical/collaboration study and trial, advertising and promotional, refiling justifications, and pricebook support. Manages post‐market regulatory surveillance activities including complaint handling, medical device problem reporting, and recalls/field actions reporting to FDA and Health Canada. This includes but not limited to supporting mirror regulatory reporting to non‐United States and Canadian regulatory authorities. Acts as direct interface to FDA and Health Canada to coordinate strategic actions and responses to regulatory agency requests related to pre‐ and post‐market activities. Co‐leads United States and Canadian regulatory inspections, and supports global regulatory inspections for the supported BAs/BLs. Manages FDA and Health Canada product and sites registration activities. Ensures compliance to relevant medical device and drug regulations and standards, such as FDA 21 CFR 820, Canada MDR, ISO 13485, ISO 14971, and ISO 9001. Monitors, interprets, and where possible influences pre‐ and post‐market regulations, guidances, and standards across the United States (inc., state‐level) and Canada; evaluates the impact of those changes; and implements strategic solutions as needed to ensure compliance. Defines regional processes and tools relevant to the functional area(s) that comply with global regulatory requirements. Participates in the development and deployment of global processes and tools including deployment, training, and monitoring. Supports regional and global projects as assigned. Team Development Provides leadership, for hiring, coaching and performance review for all direct and indirect functional reports. Demonstrates full understanding and application of management approaches for work direction, motivation, and performance managementStrategic Leadership Provides strategic leadership for pre‐market commercialization and post‐market compliance activities including interpretation, implementation, and compliance monitoring of policies and processes relevant to the functional area(s). Aligns team objectives with regional and global expectations, and supports the implementation of business and functional initiatives. Provides regional and global strategic leadership on pre‐ and post‐market topics and issues. Effectively communicates and collaborates with government agencies, key stakeholders, external customers, and employees at all levels. Education: BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas. Experience and Required Skills: • Typically Minimum of 15+ years of relevant experience, with at least 10+ year’s direct experience in the medical device industry. • Demonstrates and applies advanced knowledge of United States’ FDA and Canada’s Health Canada pre‐ and post‐market regulatory requirements, inc. regulatory affairs, clinical affairs, surveillance reporting, quality system requirements, and other applicable regulatory requirements. • Strong management skills with the ability to lead cohesive and productive teams across multiple countries and cultures. • Effective verbal and written communication in individual and group settings. • Demonstrated experience and a track record of success managing projects. 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 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 *LI-WC1 Organization: Siemens Healthineers Company: Siemens Medical Solutions USA, Inc. Experience Level: Experienced 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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