Regulatory Affairs Specialist

Job description

We anticipate the application window for this opening will close on - 18 Nov 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 LifeThe Cardiovascular Surgery Operating Unit focuses on a specialized clinical environment designed to support complex surgical procedures involving the heart and major blood vessels. The OU represents end stage treatment in the care continuum for many cardiovascular diseases, and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac OR by offering an unparalleled depth and breadth of portfolio. Key Technologies • Surgical heart valves • Cardiac OR solutions (e.g., blood management, cannulae) • Extracorporeal life support (ECLS) • Coronary artery bypass grafting (CABG) solutions At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This position will be based in Mounds View, MN. The Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and therapies to markets worldwide. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. Role and Responsibilities: Define the regulatory strategy for product maintenance for existing approved products. Team with other operating unit regulatory personnel and international regulatory staff to provide support for new products/therapies and changes to existing products. Work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare regulatory (e.g., FDA/Notified Body) submissions product changes, as required, to ensure timely approvals for clinical studies and market release. Review significant product submissions with manager. Interact directly with FDA/Notified Body and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager. Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed. Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel. Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams. Provide feedback and on-going support to product development teams for regulatory issues and questions. Develop proficiency in domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies. Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work. Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. Bachelor’s degree required Minimum of 2 years of experience in regulatory affairs in the medical device industry. Or advanced degree with a minimum of 0 years of experience in regulatory affairs in the medical device industry Nice to Have (Preferred Qualifications): Advanced degree in a scientific discipline (engineering, physical/biological, or health sciences) Experience with 510(k)/IDE/PMA device product submissions, EU regulations (MDR) and other worldwide submissions and clearances Experience performing advertising and promotion reviews for medical devices Experience with FDA and international regulatory agency requirements Effective interpersonal skills Effective team member Ability to comprehend principles of engineering, physiology and medical device use Ability to effectively manage multiple projects and priorities Proficient computer skills Project management skills Excellent oral and written skills Excellent analytical thinking skills 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 competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$74,400.00 - $111,600.00 ‌ This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary ra