Hiring: Regulatory Affairs Specialist Company: Medtronic Location: Mounds View, MN Job Posted Time: 2026-09-12 13:45:18 Employment Type: Remote Target Skills & Keywords : Agile, Microsoft Office About the job Experience: •2 Years of medical device regulatory experience with Bachelor’s degree. Or minimum 0 Years of medical device regulatory experience with an advanced degree •Minimum 2 Years of medical device regulatory experience with Bachelor’s degree. Or minimum 0 Years of medical device regulatory experience with an advanced degree Required Skills: •This position will be based in Mounds View, MN. •Assist in preparing regulatory strategies/plans and worldwide compliance requirements. 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. •Negotiate with international agencies, as needed. All significant issues will be reviewed with the supervisor. •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. Qualifications: •Master of Science Degree •In depth experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards •Solid functional working knowledge of SaMD and SiMD •Positive track record engaging with regulators •History of successful device submissions •Strong negotiation skills and written/oral communication skills •Strong organizational skills and time management skills •Demonstrated capacity to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines •Demonstrated capacity to work independently and under general direction only •Computer skills; MS Office, MS Project, Adobe Acrobat and Agile Compensation: •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!