Principal Regulatory Affairs Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Principal Regulatory Affairs Specialist is responsible for providing regulatory leadership and strategic support for product development, lifecycle management, and global market access activities for the Shiley product portfolio. This role partners cross-functionally with R&D, Quality, Manufacturing, Clinical, Marketing, Operations, and globalization regulatory teams to develop and execute regulatory strategies that support business objectives while ensuring compliance with applicable global regulations and standards. The individual in this role operates with a high degree of independence, influences cross-functional decision-making, and may serve as the regulatory lead for complex projects, product portfolios, or business-critical initiatives. Medtronic At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Our Purpose  This role entails developing and implementing regulatory strategies, managing regulatory submissions and internal documentations, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results through providing guidance and mentorship to team members, supporting their development and helping them navigate complex regulatory requirements. Collaborate closely with cross-functional partners such as R&D, clinical, operations, and marketing to ensure regulatory needs are integrated into product development and lifecycle management. Occasionally represent the company in discussions with regulatory bodies and industry groups, supporting regulatory compliance and business objectives supporting Acute Care & Monitoring achieve regulatory success and maintain a competitive edge. Come for a job, stay for a career! A Day in The Life:  The Principal Regulatory Affairs Specialist (Pr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Shiley™ product within the Acute Care and Monitoring operation unit. Activities include participation in new product development and change development projects, review and approve design control documentation, regulatory change assessments, author regulatory documents (MDR Technical Documents, STEDs, 510ks, letter-to-file) and supporting EU MDR implementation. The Pr. RAS role translates regulatory requirements into project/product requirements and collaborates cross-functionally, while ensuring timely and high-quality execution of assigned regulatory deliverables. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices. Responsibilities may include the following and other duties may be assigned: Directs or performs coordination and preparation of document packages for regulatory submissions. Supports change control activities to support global approval and implementation of product and process changes. Leads or compiles all materials required in CE-Mark and FDA submissions, internal regulatory documentations, license renewal and annual registrations. Teams with other business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and