DirectJobHub
Jobs · Legal · Minnesota

Principal Regulatory Affairs Specialist - Onsite

Medtronic · Minneapolis, MN · 2 mo ago
On-siteLegal$120k–$180k/yrFull-time

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.

About the role

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.

This role is based onsite 4 days a week at our Minnesota Rice Creek East facility.

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.

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.

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.

Skills

  • 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.

Benefits

The following benefits and additional compensation are available to regular employees who work 20+ hours per week:

  • Health, Dental, and Vision insurance.
  • Health Savings Account and Healthcare Flexible Spending Account.
  • Life insurance and Long-term disability leave.
  • Dependent daycare spending account and Tuition assistance/reimbursement.
  • Simple Steps (global well-being program).
  • Incentive plans, including the Medtronic Incentive Plan (MIP).
  • 401(k) plan plus employer contribution and match.
  • Paid time off and 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).

Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Pay

Salary ranges for U.S (excluding PR) locations: $120,000.00 - $180,000.00. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

Schedule

This role is onsite 4 days a week at our Minnesota Rice Creek East facility.

Similar jobs