Sr. Regulatory Affairs Specialist - Global Markets

We anticipate the application window for this opening will close on - 20 Jun 2026 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                  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.SENIOR REGULATORY AFFAIRS SPECIALIST  - Global Markets (High-Risk Devices) Neuromodulation 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 Pelvic Health 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   Onsite 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.  We are looking for a passionate Senior Regulatory Affairs Specialist who has experience developing global regulatory strategies in partnership with our business unit project teams and geography regulatory partners for our innovative high-risk medical device portfolio. Role Overview  The Sr. Regulatory Affairs Specialist develops global regulatory strategies and leads worldwide submissions for high-risk medical devices.  They will manage strategy meetings, submissions, and deficiency responses to ensure approval for new product entry and device changes.  They will also ensure global compliance, participate in audits, and provide support to project teams.    Key Responsibilities Global Regulatory Strategy & Submissions: Partner with business unit and geography regulatory teams to develop and execute global submission strategies, deficiency responses, and product registration plans for new and modified products. Product Lifecycle Management: Provide regulatory assessments and approvals for engineering change orders, labeling changes, and product releases to ensure continuous compliance across global markets. Agency Interaction & Compliance: Act as a key liaison to international regulatory agencies at the reviewer level; support manufacturing site registrations, audits, post-market vigilance, and product recalls. Cross-Functional Technical Support: Collaborate with R&D, engineering, and supply chain teams to identify, address, and resolve potential regulatory obstacles and compliance blocks throughout the product lifecycle. Regulatory Intelligence & Mentorship: Maintain up-to-date knowledge of global regulations and industry standards to inform company strategy; provide guidance and training to junior team members. Strategic Focus:   Lead the strategic direction and planning for global regulatory projects, ensuring timely market approvals and compliance with applicable regulations   Must Have: Minimum Requirements  Bachelor’s degree in a scientific discipline or equivalent with 4 years of relevant experience, or an advanced degree with 2 years of experience.    Nice To Have  A minimum of 2 years of experience in medical device regulatory affairs. Knowledge in global regulations, including ISO 13485, MDSAP, and MDR 5-8 years of industry experience, with at least 2-3 years in regulatory, engineering, clinical, or quality roles.  Advanced degree in a scientific, engineering, or health discipline.  In-depth experience with global regulatory requirements, including MDR, ISO 14971, ISO 13485, MDSAP, and quality standards  History of successful international device submissions, including LATAM, APAC, and CEEMEA regions Experience with Class III medical devices (PMA) For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and