Principal Regulatory Affairs Specialist - Onsite

Medtronic•Minneapolis, MN

5d•$120,000 - $180,000•Onsite

About The Position

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. Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. Our Neuromodulation operating unit delivers advanced therapies for chronic pain, movement disorders, and nervous system conditions, offering RF ablation, vertebral augmentation, SCS, DBS, and targeted drug delivery. Through proven technology, clinical evidence, and innovation, we provide personalized solutions that restore function and enhance quality of life. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week at our Minnesota Rice Creek East facility to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. The Principal Regulatory Affairs Specialist will play a key role in launching new products and sustaining the Pain Interventions product portfolio. As a core member of the new product development (NPD) team, the principal specialist works directly with the team from the opportunity phase through commercialization. The principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide. Sustaining regulatory responsibilities includes reviewing product labeling changes to ensure that regulatory requirements continue to be met, documenting “no file” decisions, reviewing promotional materials, and ensuring that our product technical documentation is current and accurate. This position is best suited for individuals with a broad background across the full regulatory life cycle of medical devices and strong working knowledge and experience in reviewing advertising and promotional materials for medical devices.

Requirements

Bachelor’s degree required
Minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience.
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.
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.

Nice To Haves

Experience successfully achieving FDA clearance through a 510(k) submission
Experience interacting directly with the FDA
Experience managing or contributing to multiple regulatory submissions
Familiarity with medical device regulatory lifecycle management.

Responsibilities

Provide regulatory affairs support for new products, product modifications, and currently marketed products across domestic and international markets.
Prepare, review, and support regulatory submissions, including FDA submissions (Pre-Subs, 510(k)s), CE Mark, and other international filings, to support timely approvals and market release.
Collaborate with regulatory affairs specialists, engineers, technical experts, and cross-functional teams such as engineering, quality, clinical, marketing, and business units to resolve regulatory issues and support product development.
Interact with FDA and other regulatory authorities at the reviewer level, including participation in submission reviews, issue resolution, and negotiations as needed.
Review labeling, promotional, and advertising materials, as well as product change documentation, to determine whether regulatory submission or approval is required.
Support regulatory compliance activities, including manufacturing site registration, audits, recalls, and maintenance of required regulatory documentation.
Maintain current knowledge of applicable domestic and international regulations, guidelines, and standards, and apply that knowledge to regulatory strategy and execution.
Provide regulatory strategy input and technical guidance for new technologies and product changes, considering global regulatory requirements.
Communicate business and product information to international regulatory teams and business partners to support development of regulatory strategies and requirements.
Maintain strong working relationships with regulatory agency personnel and internal stakeholders.
Create or revise departmental procedures as needed to improve operations or reflect changing regulatory requirements.
Manage multiple projects and priorities to meet business and project timelines.
Mentor or supervise other regulatory affairs staff, as assigned.
Perform other duties as assigned.

Benefits

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)
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)