Regulatory Affairs Specialist

Job Opening Application window closes on 17 Jun 2026. Location Mounds View, MN. Role Overview The Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce cardiac arrhythmia and heart failure products and External Pacemaker to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with license maintenance including renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations. Role and Responsibilities Provide on‑going support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations. Provide business and product information to enable development of strategies and requirements, as well as communicate that information to the Project teams. Provide regulatory support for currently marketed products as necessary. This includes reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required. Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines. Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, Medtronic requirements on testing, etc. Provide regulatory analysis of product portfolio and review with other functional resources, such as Marketing, Global Supply Chain, etc., to ensure Diagnostics and EPG portfolio is aligned with existing portfolio. Maintain Regulatory Affairs product files to support compliance with regulatory requirements. Work under general supervision following established procedures. Independently determines and develops approach. Frequent inter‑organizational contact and some external contacts. Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas. Provide training and support to other members of the department. Other tasks, as required. Must Have; Minimum Requirements Bachelor’s degree in a technical discipline. Minimum 2 years of medical device regulatory experience with a Bachelor’s degree, OR minimum 0 years of experience with an advanced degree. Nice To Have Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA, PMDA), and working with cross‑functional project teams. Master of Science Degree. Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards. Strong negotiation skills and written/oral communication skills. Strong organizational skills and time‑management skills. Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines. Ability to work independently and under general direction only. Computer skills; MS Office, MS Project, Adobe Acrobat and Agile. Foreign Degree Requirement 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For office roles: the employee is regularly required to be independently mobile, interact with a computer, and communicate with peers and co‑workers. Please contact your manager or local HR to understand the work conditions and physical requirements specific to this role. U.S. Work Authorization & Sponsorship 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 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). Benefits for regular employees working 20+ hours per week include 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). Benefits for all regular employees include incentive plans; 401(k) plan plus employer contribution and match; short‑term disability; paid time off; paid holidays; employee stock purchase plan; employee assistance program; non‑qualified retirement plan supplement; and capital accumulation plan (available to VPs and above, or subject to IRS earning minimums). Temporary employees are eligible for paid sick time, as required under applicable state law, and the employee stock purchase plan. Equal Employment Opportunity 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. Medtronic will provide reasonable accommodations for qualified individuals with disabilities. Medtronic will consider for employment 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