Principal Regulatory Affairs Specialist - Onsite

Job description

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 RF ablation, vertebral augmentation, 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. The Principal Regulatory Affairs Specialist will play a key role in launching new products and sustaining the Pain Interventions product portfolio. As a core member of the new product development (NPD) team, the principal specialist works directly with the team from the opportunity phase through commercialization. The principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide. Sustaining regulatory responsibilities includes reviewing product labeling changes to ensure that regulatory requirements continue to be met, documenting “no file” decisions, reviewing promotional materials, and ensuring that our product technical documentation is current and accurate. This position is best suited for individuals with a broad background across the full regulatory life cycle of medical devices and strong working knowledge and experience in reviewing advertising and promotional materials for medical devices. Responsibilities may include the following and other duties may be assigned. Provide regulatory affairs support for new products, product modifications, and currently marketed products across domestic and international markets. Prepare, review, and support regulatory submissions, including FDA submissions (Pre-Subs, 510(k)s), CE Mark, and other international filings, to support timely approvals and market release. Collaborate with regulatory affairs specialists, engineers, technical experts, and cross-functional teams such as engineering, quality, clinical, marketing, and business units to resolve regulatory issues and support product development. Interact with FDA and other regulatory authorities at the reviewer level, including participation in submission reviews, issue resolution, and negotiations as needed. Review labeling, promotional, and advertising materials, as well as product change documentation, to determine whether regulatory submission or approval is required. Support regulatory compliance activities, including manufacturing site registration, audits, recalls, and maintenance of required regulatory documentation. Maintain current knowledge of applicable domestic and international regulations, guidelines, and standards, and apply that knowledge to regulatory strategy and execution. Provide regulatory strategy input and technical guidance for new technologies and product changes, considering global regulatory requirements. Communicate business and product information to international regulatory teams and business partners to support development of regulatory strategies and requirements. Maintain strong working relationships with regulatory agency personnel and internal stakeholders. Create or revise departmental procedures as needed to improve operations or reflect changing regulatory requirements. Manage multiple projects and priorities to meet business and project timelines. Mentor or supervise other regulatory affairs staff, as assigned. Perform other duties as assigned. Must Have: Minimum Requirements Bachelor’s degree required Minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience. Nice to Have Experience successfully achieving FDA clearance through a 510(k) submission Experience interacting directly with the FDA Experience managing or contributing to multiple regulatory submissions Familiarity with medical device regulatory lifecycle management. 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 Requirements The 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 make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. ‌ Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and comp