Regulatory Affairs Specialist

Regulatory Jobs; Minneapolis (MN); On-site; USD 74,000 - 112,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

401(k) with company match

Paid time off

Job summary

Medtronic in Minnesota is seeking a Regulatory Affairs Specialist to support regulatory strategy, submissions, approvals, and compliance for medical devices marketed globally. This onsite role collaborates with cross-functional teams to maintain product registrations and ensure regulatory compliance across markets.

Based at Medtronic’s Rice Creek East campus with a four-day in-office schedule, you will prepare submissions (FDA/EU), review labeling, and advise product teams throughout the

Qualifications

• Bachelor's degree in a scientific discipline and 2+ years of regulatory affairs experience or related roles.
• Experience with medical devices regulated under FDA requirements (Class II/III).
• Experience preparing or supporting regulatory submissions (510(k), PMA, EU MDR, or international filings).
• Knowledge of FDA/EU MDR ISO 13485 and ISO 14971 standards.
• Proficiency with Microsoft Office applications.

Responsibilities

• Prepare and support regulatory submissions for the US, EU, Canada, and other markets.
• Collaborate with engineering, quality, clinical, and manufacturing teams on regulatory requirements for changes/new products.
• Develop regulatory documentation to support registrations, renewals, annual reports, and change notifications.
• Review labeling, technical docs, and design changes for regulatory impact.
• Support interactions with regulatory authorities and respond to inquiries under guidance.
• Partner with global regulatory teams to obtain and maintain registrations.

Skills

Regulatory knowledge

Regulatory submissions

FDA regulations

MS Office

Education

Bachelor's degree in a scientific discipline

Advanced degree in engineering or health sciences

Job description

We anticipate the application window for this opening will close on - 24 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

Our Neuroscience portfolio includes the Neuromodulation and Pelvic Health Operating Units, which deliver implantable and minimally invasive therapies to address chronic pain, movement disorders, bladder and bowel control conditions, and other nervous system disorders. The Regulatory Affairs function partners with product development, quality, clinical, manufacturing, and global regulatory teams to support product registrations, regulatory compliance, and lifecycle management activities across global markets.

Check us out on LinkedIn: Medtronic Brain Modulation and Pain Interventions

Check us out on LinkedIn: Medtronic Pelvic Health

This position is based at Medtronic’s Rice Creek East campus in Minnesota and follows an onsite work model with a minimum of four days per week in the office.

The Regulatory Affairs Specialist supports regulatory strategy, submissions, approvals, and compliance activities for medical devices marketed globally. This role partners with cross-functional teams and international regulatory stakeholders to facilitate product registrations, support product changes, and maintain compliance with applicable regulatory requirements.

Primary Responsibilities

• Prepare and support regulatory submissions for the United States, European Union, Canada, and other global markets.
• Collaborate with engineering, quality, clinical, and manufacturing teams to assess regulatory requirements for product changes and new product introductions.
• Develop regulatory documentation to support product registrations, renewals, annual reports, and change notifications.
• Review product labeling, technical documentation, and design changes for regulatory impact and compliance.
• Support interactions with regulatory authorities and respond to regulatory inquiries under the manager's guidance.
• Partner with global regulatory teams to obtain market approvals and maintain product registrations.
• Support regulatory compliance activities, including manufacturing site registrations, audits, vigilance reporting, and recall-related activities.
• Provide regulatory guidance to product development teams throughout the product lifecycle.

Required Qualifications

• Bachelor's degree in a scientific discipline and 2+ years of experience in regulatory affairs, quality, clinical, or medical device-related roles.
• Experience supporting medical devices regulated under FDA requirements, including Class II and/or Class III products.
• Experience preparing or supporting regulatory submissions, including 510(k), Premarket Approval (PMA), European Union Medical Device Regulation (EU MDR), or international regulatory filings.
• Knowledge of FDA regulations, EU MDR requirements, ISO 13485, and ISO 14971 standards.
• Proficiency with Microsoft Office applications.

Preferred Qualifications

• 2+ years of regulatory affairs experience within the medical device industry.
• Advanced degree in engineering, biological sciences, physical sciences, or health sciences.
• Experience supporting global product registrations and regulatory approvals across multiple regions.
• Experience working in regulated biotechnology or medical device manufacturing environments.
• Experience interacting with regulatory agencies and supporting agency responses.

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):$74,400.00 - $111,600.00

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 applies solely to candidates hired within the United States (local-market compensation and benefits will apply to 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, andSimple 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), andCapital 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

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.