Medtronic
Healthcare
RegulatoryAffairsSpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Regulatory Affairs Specialist at Medtronic. Skills: Regulatory affairs, Product registration, Medical device regulatory. Develop strategies for worldwide product registration. Provide advice on regulatory requirements”
Industry & Context.
What They're Looking For.
Must Have
Bachelor's degree in technical discipline, Minimum 2 Years medical device regulatory experience, Minimum 0 Years medical device regulatory experience with advanced degree
Nice to Have
Experience in regulated biotechnology environment, Experience with regulatory submissions, Experience interacting with regulatory agencies, Experience working with cross-functional project teams, Master of Science Degree, Experience with FDA requirements, Experience with ISO 14971, Experience with ISO 13485, Experience with other global regulatory requirements, Experience with global quality standards, Ability to multitask, Ability to support multiple projects, Ability to function on global basis, Ability to prioritize, Ability to conduct team meetings, Ability to meet project deadlines, Ability to work independently, Ability to work under general direction
What You'll Do.
Develop strategies for worldwide product registration
Provide advice on regulatory requirements
Prepare worldwide submissions
Negotiate product approval
Assist with license maintenance
Assist with design change notification
Assist with manufacturing change notification
Assist with QMS audit
Assist with Manufacturing site registrations
Provide ongoing support to project teams
Interpret regulations
Provide business information
Provide product information
Communicate information to project teams
Provide regulatory support for marketed products
Review changes to devices
Review changes to documentation
Prepare submissions for regulatory agencies
Prepare reports for regulatory agencies
Participate in project team meetings
Review specifications
Define distribution method
Define Medtronic requirements on testing
Provide regulatory analysis of product portfolio
Review product portfolio with functional resources
Ensure portfolio alignment
Maintain Regulatory Affairs product files
Support compliance with regulatory requirements
Keep current on global directives
Keep current on harmonized standards
Keep current on procedures
Communicate changes affecting cross functional areas
Provide training to department members
Support department members
How You'll Work.
Team & Collaboration
Project teams; Cross-functional areas; Other functional resources; Marketing; Global Supply Chain
Communication Scope
Written communication; Oral communication
Process & Methodology
Project teams, Project deadlines
Full Job Description
We anticipate the application window for this opening will close on - 17 Jun 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. # **A Day in the Life** The Cardiac Rhythm Management operating group is a division within Medtronic focused on developing and manufacturing medical devices and solutions for the management of cardiac arrhythmias and heart failure. This group’s product portfolio includes implantable pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, and remote monitoring systems. CRM’s mission is to improve patient outcomes and quality of life by providing innovative therapies for the detection, prevention, and treatment of abnormal heart rhythms. The group collaborates closely with healthcare professionals and leverages advanced technology and data-driven insights to drive improvements in cardiac care. 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** develops strategies for worldwide product registration with global regulatory agencies to introduce cardiac arrhythmia and heart failures products and External Pacemaker to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with the license maintenance including renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations. **Role and Re
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