Associate Regulatory Affairs Specialist

We anticipate the application window for this opening will close on - 16 Oct 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 Cardiac Ablation team within the Electrophysiology Therapies operating unit is focused on disrupting the Electrophysiology (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, to date the Cardiac Ablation business has 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 as we work together to engineer the extraordinary.
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 will include a blend of international regulatory affairs, regulatory operations activities, and project coordination work. Regulatory affairs work will focus on international submission activities including maintaining regulatory approvals, renewals, registrations and tender activities and assessment of device changes for registration implications. Regulatory operations work will involve supporting regulatory systems relating to product release, economic operator verification, registration and listing, data management and initiatives to maintain integrity of CAS regulatory information, among other activities.
Roles and Responsibilities
Understanding global regulatory requirements and how to research detailed requirements.
Contributing to global product registration maintenance, including EU MDR Technical Documentation/MDD Technical Files.
Assessing device changes for registration implications and electronically notifying geographies of regulatory changes.
Routing regulatory documents for approvals in electronic systems, maintaining approval information, and maintaining electronic document collections.
Supporting requests to systems relating to product release, economic operator verification, and registration and listing.
Participating in preparation for internal and external regulatory audits.
Compiling materials required for new global product submissions, license renewals and change submissions. Monitoring, maintaining, and improving global regulatory tracking/control systems.
Requesting, obtaining and maintaining FDA Certificate of Foreign Government (CFGs) including notarization and legalization, EC/ISO certificates and various other regulatory documents.
Keeping abreast of regulatory procedures and changes.
Performing other regulatory duties as needed.
Must Have (Minimum Requirements)
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
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 medical device industry
Demonstrated technical writing skills
Strong computer skills, including word processing, excel and 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
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.
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