Senior Regulatory Affairs Specialist

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life 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 implementing regulatory strategies, managing regulatory submissions, 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 Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Microstream™ Capnography Monitoring product portfolio within the Acute Care and Monitoring operation unit. Activities include participation in change development projects, review and approve design control documentation, regulatory change assessments, author regulatory documents (MDR Technical Documents, STEDs or 510ks) and supporting EU MDR implementation. The Sr. 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, license renewal and annual registrations. Teams with 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 resolve questions from regulatory agencies. Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance. Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements. May have direct interaction with regulatory agencies on defined matters. Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed. Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives. Key Skills & Experience Level 8 Honor’s Degree Science or Engineering bachelor's degree/master's with a minimum of 5 years of relevant experience, preferably with Class III Medical Devices. A Regulatory Affairs qualification is desirable, but not mandatory. Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required. You are a dynamic team player and can work effectively and pro-actively on activities ... (truncated, view full listing at source)