Regulatory Affairs Specialist

We anticipate the application window for this opening will close on - 22 Aug 2026   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                     Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. Our Neuromodulation operating unit delivers advanced therapies for chronic pain, movement disorders, and nervous system conditions, offering SCS, DBS, and targeted drug delivery. Through proven technology, clinical evidence, and innovation, we provide personalized solutions that restore function and enhance quality of life.  Check us out on LinkedIn: Medtronic Brain Modulation and Pain Interventions At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week at our Minnesota Rice Creek East facility to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. In collaboration with leading clinicians, researchers, and scientists worldwide, Role Overview   The Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to the market. This role involves:  Providing expert advice on regulatory requirements  Preparing submissions  Supporting approval activities  Assisting with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations  Responsibilities Include, But Are Not Limited To: Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products.  Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.  Prepare FDA, European, and Canadian submissions for product changes to ensure timely market release approvals.  Review regulatory issues with the manager as necessary and support the resolution of submission issues with engineering partners, geography regulatory partners, and regulatory agencies.  Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls.  Provide regulatory support for currently marketed products, including reviewing labeling and changes to existing devices and documentation.  Provide feedback and ongoing support to product development teams for regulatory issues and questions.  Interact with FDA and international regulatory agencies on assigned projects/products, with significant issues reviewed with the manager.  To Be Successful in This Role   Medical Device Experience:  Experience in the medical device industry, including exposure to Class II and/or Class III medical devices (510(k) and some PMA).  Regulatory Submission Expertise:  Experience preparing and supporting regulatory filings to the FDA (including 510(k) and some PMA), EU MDR, and other global regulatory agencies.  Knowledge of Regulatory Requirements:  Understanding of FDA requirements, guidance documents, EU MDR, ISO 14971, ISO