Senior Regulatory Affairs Spec

Medtronic; Mounds View (MN); On-site; USD 92,000 - 138,000; Full time

Benefits offered by this job

Medtronic Incentive Plan (MIP)

Health, Dental and vision insurance

Health Savings Account

Job summary

Medtronic in Minnesota is seeking a Senior Regulatory Affairs Specialist focused on software-based medical devices. You will author and clear submissions via FDA eStar and EU Notified Body, leveraging IEC 62304 and software lifecycle expertise.

This role is based in Mounds View, with an emphasis on cross-functional collaboration and on-site work at least four days per week. You will develop global regulatory strategies and maintain regulatory files for a diverse portfolio.

Qualifications

• Bachelor's degree in a technical discipline is required.
• Minimum 4 years of medical device regulatory experience with a bachelor's degree.
• Or minimum 2 years of medical device regulatory experience with an advanced degree.

Responsibilities

• Prepare US and EU MDR submissions for new products and changes for timely approval.
• Develop regulatory strategies and ensure worldwide compliance.
• Provide regulatory support and documentation for current products; review labeling and changes.

Skills

Regulatory experience

Software-based devices

Regulatory strategy

Education

Bachelor's degree in a technical discipline

Advanced degree

Tools

FDA eStar

EU Notified Body submissions

IEC 62304

Regulatory submissions

Job description

We anticipate the application window for this opening will close on - 31 Aug 2026

A Day in the Life

We are looking for a passionate Senior Regulatory Affairs Specialist in our Cardiac Ablation Solutions Operating Unit to work primarily on software-based medical devices. The candidate must have successful experience authoring and clearance of software submissions using FDA's eStar program as well as submissions to the EU Notified Body. A deep understanding of software engineering standard IEC 62304 and experience with software lifecycle process is also key.

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.

Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Diagnostic products, Programmers and Programming Software and accessories for Pacemakers and Defibrillators, Patient Monitors, and Software as a Medical Device 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 Responsibilities

• Prepare US and EU MDR submissions for new products and their product changes as required to ensure timely approval for market release. Review significant regulatory issues with Manager, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.
• Prepare 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. 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

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

• Bachelor’s degree in a technical discipline
• Minimum 4 Years of medical device regulatory experience with Bachelor’s degree
• Or minimum 2 Years of medical device regulatory experience with an advanced degree

Nice to Have

• Master of Science Degree
• Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and PMDA), and working with cross-functional project teams.
• In depth experience with FDA requirements, FDA guidance documents, EU Medical Device Regulation, IEC 62304, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• 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
• 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

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

• Salary ranges for U.S (excl. PR) locations (USD):$92,000.00 - $138,000.00
• 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)
• The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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).
• 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), and 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:

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.

Medtronic offers a competitive Salary and flexible Benefits Package

Medtronic Benefits And Compensation Plans