OneMain Financial Jobs

We anticipate the application window for this opening will close on - 7 May 2026

Position Description:

Sr. Regulatory Affairs Specialist for Medtronic, Inc. located in Mounds View, MN. Responsible for developing regulatory strategies, preparing U.S. regulatory submissions, and obtaining and maintaining approval for products and therapies to markets worldwide. Assess the regulatory impact of changes to cleared & approved products and processes and coordinate the implementation of any resulting regulatory strategy. Prepare document packages for regulatory submissions from all areas of company and inspections for Food and Drug Administration Quality Systems Regulation (QSR). Compile all materials required in submissions, license renewal and annual registrations. Recommend changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance. Work on 510(k) submissions for US Class II medical devices. Work on EU MDD (Medical Device Directive) technical files and/or EU Medical Device Regulation (MDR) technical documentation and support the review of other Device History File (DHF) or EU deliverables including Clinical Evaluation Reports, Post-Market Clinical Follow Up, Risk Management, and Design Verification/Validation. Responsible for total product life-cycle regulatory activities including product development, obtaining approval and post market changes. Ensure product adherence to QSR 21 CFR 820, EU MDD 93/42/EEC or EU MDR 2017/745, and ISO 13485. Provide product support for patient-contacting devices requiring ISO 10993-1 for Biocompatibility, electrical devices in scope of IEC 60601 and medical device software in scope of IEC 62304. Support Outside the United States (OUS) regulatory requirements beyond the U.S. and EU. The position works as a hybrid model and will be onsite at the Mounds View, MN location 4 days per week. Relocation assistance is not available for this position. #LI-DNI.

Basic Qualifications:

Requires a Master’s degree in Regulatory Affairs, Biomedical Engineering, Chemistry, or closely related field and three (3) years of experience as a Regulatory Affairs Specialist, R&D Engineer or related occupation in Regulatory Affairs / R&D Engineering; OR a Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, Chemistry, or closely related field and five (5) years of experience as a Regulatory Affairs Specialist, R&D Engineer or related occupation in Regulatory Affairs / R&D Engineering. Must possess a minimum of three (3) years of experience with each of the following: 510(k) submissions for US Class II medical devices; Authoring or maintenance of EU MDD technical files & EU MDR technical documentation; Reviewing DHF or EU deliverables including Clinical Evaluation Reports, Post-Market Clinical Follow Up, Risk Management, and/or Design Verification/Validation; Supporting product life cycle including product development, obtaining approval/clearance and post-market changes; QSR 21 CFR 820, EU MDD (93/42/EEC) or EU MDR (2017/745), and ISO 13485; Regulatory support of ISO 10993-1, IEC 60601, and IEC 62304 compliance; and Supporting OUS regulatory requirements outside of the U.S. and EU.

Salary: $110,200 to $138,000 per year

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 plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

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.

This life-changing career is yours to engineer . 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.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .

For updates on job applications, please go to the candidate login page and sign in to check your application status.

If you need assistance completing your application please email AskHR@medtronic.com

To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com