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Johnson & Johnson is hiring for a Sr. Regulatory Affairs Specialist to be located in Santa Clara, CA or remote in the United States. The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical, Inc. (SWMI) specifically the Reducer Product business. The Sr. Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements with a focus on the United States and Canada. Under direction of responsible Regulatory Affairs Management, acts as a decision-maker on regulatory issues, assures that registration/renewal deadlines are met, and supports new product development.