Senior Regulatory Affairs Specialist - Onsite

We anticipate the application window for this opening will close on - 1 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 **Pelvic Health** Operating Unit advances care for patients living with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies, including sacral and tibial solutions. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor, these programmable therapies deliver personalized treatment supported by strong clinical evidence and long-term outcomes—helping improve confidence, independence, and quality of life. Check us out on LinkedIn: [Medtronic Pelvic Health](https://www.linkedin.com/showcase/medtronic-pelvic-health/posts/?feedView=all) 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, Medtronic offers the broadest range of innovative medical technology. The company strives to provide products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers worldwide. Saving lives is part of our everyday DNA. Real people with debilitating conditions can now be given back active lives through the restorative therapies that we provide. Therefore, we are looking for a passionate **Senior Regulatory Affairs Specialist** who has direct experience submitting regulatory submissions for both the Americas and the EU. **Role Overview** The Senior 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 - Negotiating their approval - Assisting with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations. - 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 approval for market release. - Partner with geography partners to develop regulatory strategy, submit submissions, or respond to regulators. - Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed. - Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls. - Provide regulatory support for currently marketed p…