Associate Regulatory Affairs Specialist

Medtronic; Mounds View (MN); On-site; USD 61,000 - 91,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

Tuition assistance/reimbursement

401(k) plan with employer match

Life insurance

Well-being program

Job summary

Medtronic is seeking an Associate Regulatory Affairs Specialist in Minneapolis, MN. The role involves supporting international submissions, regulatory operations, and project coordination.

You will work under guidance to maintain regulatory approvals and manage listing data, among other duties, contributing to global regulatory excellence. Ideal candidates have a Bachelor’s degree and strong technical writing skills, with experience in medical devices.

Qualifications

• Bachelor's degree 0 years of regulatory affairs or related experience.

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 notify geographies of regulatory changes.

Skills

Regulatory affairs

Technical writing

Project coordination

Regulatory submissions

Education

Bachelor's degree

Tools

Excel

PowerBI

Word processing

Job description

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 Life

The 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.

Associate Regulatory Affairs Specialist

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)

• 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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$60,800.00 - $91,200.00

This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

• 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
• Simple Steps (global well‑being program)

The following benefits and additional compensation are available to all regular employees:

• 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 (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: Medtronic benefits and compensation plans.

EEO 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. If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which 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 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.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R∙D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning. These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need.

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