Regulatory Affair Specialist - Onsite

Medtronic plc; Minneapolis (MN); On-site; USD 74,000 - 112,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with match

Tuition assistance

Job summary

Medtronic in Minneapolis, MN is seeking a Regulatory Affairs Specialist to lead regulatory strategy, submissions, and compliance for globally marketed medical devices. This onsite role partners with engineering, quality, clinical, and manufacturing teams to navigate regulatory requirements across multiple markets.

Responsibilities include preparing submissions (510(k), PMA, EU MDR), maintaining registrations, and supporting labeling, change notifications, and audits.

Qualifications

• Bachelor's degree in a scientific discipline and 2+ years in regulatory roles.
• Experience with FDA-regulated medical devices (Class II/III).
• Familiarity with 510(k), PMA, EU MDR filings and ISO standards.

Responsibilities

• Prepare and support regulatory submissions across US, EU, Canada, and other markets.
• Collaborate with engineering, quality, clinical, and manufacturing teams.
• Develop regulatory documentation for registrations, renewals, and changes.
• Review labeling and technical documentation for regulatory impact.
• Support regulatory inquiries and interactions with authorities.

Skills

Regulatory affairs

FDA regulations

Regulatory submissions

Microsoft Office

Education

Bachelor's degree in a scientific discipline

Job description

## Regulatory Affair Specialist - OnsiteApply: Onsite: Minneapolis, Minnesota, United States of America: Full time: Posted Today: End Date: October 24, 2026 (10 days left to apply): R68295We anticipate the application window for this opening will close on - 24 Oct 2026Careers 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.**Recruitment Fraud Alert**We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [e-mail].# **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 - $111,600.00This 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, 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:Medtronic benefits and compensation plansIt 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.