Associate Regulatory Affairs Specialist

We anticipate the application window for this opening will close on 21 Jul 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 The Cardiac Ablation team within the Electrophysiology Therapies operating unit is focused on disrupting the EP market to be the number one arrhythmia care, cardiac mapping, and ablation solutions provider for our customers and patients. Inspired by the Medtronic mission and dedicated to transforming the lives of people with cardiac arrhythmias, the Cardiac Ablation business has, to date, transformed the lives of over 1 million patients. 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. This position will be based in Mounds View, MN. The Associate Regulatory Affairs Specialist will work under the guidance of their manager and more senior regulatory specialists to provide support for the products under this business. This role combines international regulatory affairs, regulatory operations activities, and project coordination. Regulatory affairs tasks include international submission activities, maintaining regulatory approvals, renewals, registrations, tender activities, and assessment of device changes for registration implications. Regulatory operations tasks involve supporting systems related to product release, economic operator verification, registration and listing, data management, and initiatives to maintain the integrity of CAS regulatory information, among other activities. Roles And Responsibilities Understand global regulatory requirements and how to research detailed requirements. Contribute to global product registration maintenance, including EU MDR technical documentation / MDD technical files. Assess device changes for registration implications and electronically notify geographies of regulatory changes. Route regulatory documents for approvals in electronic systems, maintain approval information, and maintain electronic document collections. Support requests to systems related to product release, economic operator verification, and registration and listing. Participate in preparation for internal and external regulatory audits. Compile materials required for new global product submissions, license renewals and change submissions. Monitor, maintain, and improve global regulatory tracking/control systems. Request, obtain, and maintain FDA Certificate of Foreign Government (CFGs) including notarization and legalization, EC/ISO certificates and other regulatory documents. Keep abreast of regulatory procedures and changes. Perform other regulatory duties as needed. Must Have (Minimum Requirements) Bachelor's degree. 0 years of regulatory affairs or related experience. Nice To Have (Preferred Qualifications) Bachelor’s degree in a health profession, science and/or engineering field. Experience in the medical device industry. Demonstrated technical writing skills. Strong computer skills, including word processing, Excel, project management tools, and manipulating spreadsheets and creating presentations and using PowerBI tools. Excellent organizational, project management skills. Strong written, verbal and interpersonal skills. Notary license. Additional Degree Requirements for Foreign Credentials 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 describe the general nature and level of work being performed. They are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section are representative of those that must be met 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, employees are required to be independently mobile, interact with a computer, and communicate with peers and coworkers. 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. U.S. work authorization sponsorship (H‑1B, TN, J, etc.) is offered exclusively for principal‑level roles and above. 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. Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. Salary ranges for U.S. (excluding Puerto Rico) locations: $60,800.00 – $91,200.00. The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). The following benefits and additional compensation are available to regular employees (20+ hours per week): health, dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, life insurance, long‑term disability leave, dependent daycare spending account, tuition assistance/reimbursement, and Simple Steps (global well‑being program). All regular employees receive incentive plans, 401(k) plan with employer contribution and match, short‑term disability, paid time off, paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, non‑qualified retirement plan supplement (subject to IRS earning minimums), and capital accumulation plan (available to VPs and above or subject to IRS earning minimums). Temporary employees are eligible for paid sick time and the Employee Stock Purchase Plan. Not all benefits may apply in Puerto Rico. Equal Employment Opportunity Statement It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. Additional Consideration for Certain Geographic Locations If you are applying to perform work for Medtronic, Inc. in any position that will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. #J-18808-Ljbffr