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  1. Home
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  5. Senior Regulatory Affairs Specialist - Onsite
Medtronic logo

Senior Regulatory Affairs Specialist - Onsite

Not Disclosed•Full-TimeOn-site

location_onVÉLO, 115, North 2nd Street, North Loop, Central, Minneapolis, Hennepin County, Minnesota, 55401, United States

Apply Now

At Medtronic, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

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 Pelvic Health Operating Unit advances care for patients living with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies, including sacral and tibial solutions. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor, these programmable therapies deliver personalized treatment supported by strong clinical evidence and long-term outcomes—helping improve confidence, independence, and quality of life.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission 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.

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.

We anticipate the application window for this opening will close on 16 May 2026.

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.

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.

If you are applying to perform work for Medtronic, Inc. 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, 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.

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Skills, education and keywords

Skills: Quality Management System, Medical Device Change Management, 510(k), Pma, Eu's Medical Device Regulation, MDR.

Education: Baccalaureate degree required.

Frequently asked questions about Senior Regulatory Affairs Specialist - Onsite at Medtronic

What does a Senior Regulatory Affairs Specialist - Onsite at Medtronic do?expand_more
A Senior Regulatory Affairs Specialist - Onsite at Medtronic is responsible for the following: Direct interaction with regulatory agencies on defined matters as needed; Direct and coordinate preparation of document packages for regulatory submissions, internal audits, and inspections; Recommend changes for labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance; and Recommend strategies to achieve the earliest possible approvals for clinical trial applications.
What are the requirements for this Senior Regulatory Affairs Specialist - Onsite role?expand_more
Medtronic is looking for candidates who meet the following requirements: Baccalaureate degree; Minimum of 4 years relevant experience (or advanced degree with 2 years); U.S. work authorization required for non-Principal roles; and Degree must satisfy 8 C.F.R. § 214.2(h)(4)(iii)(A) if earned outside U.S..
Where is the Senior Regulatory Affairs Specialist - Onsite role at Medtronic located?expand_more
Senior Regulatory Affairs Specialist - Onsite at Medtronic is based in VÉLO, 115, North 2nd Street, North Loop, Central, Minneapolis, Hennepin County, Minnesota, 55401, United States. This is a on-site role.
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Work location

Work model: On-site

location_on

VÉLO, 115, North 2nd Street, North Loop, Central, Minneapolis, Hennepin County, Minnesota, 55401, United States

Minneapolis, Minnesota

Key Responsibilities

  • check_circleDirect interaction with regulatory agencies on defined matters as needed
  • check_circleDirect and coordinate preparation of document packages for regulatory submissions, internal audits, and inspections
  • check_circleRecommend changes for labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance
  • check_circleRecommend strategies to achieve the earliest possible approvals for clinical trial applications
  • check_circleLead compilation of materials required for submissions, license renewals, and annual registrations
  • check_circleMonitor and improve tracking and control systems for regulatory processes
  • check_circleMaintain up-to-date knowledge of regulatory procedures and industry changes

Requirements

  • verifiedBaccalaureate degree
  • verifiedMinimum of 4 years relevant experience (or advanced degree with 2 years)
  • verifiedU.S. work authorization required for non-Principal roles
  • verifiedDegree must satisfy 8 C.F.R. § 214.2(h)(4)(iii)(A) if earned outside U.S.

Nice to Have

Experience navigating a quality management system. Experience with Medical device or drug change management. 510(k) and/or PMA experience. Experience with the EU's Medical Device Regulation (MDR).

Benefits & Perks

check_circleHealth, Dental, and Vision Insurancecheck_circleHealth Savings Accountcheck_circleHealthcare Flexible Spending Accountcheck_circleLife Insurancecheck_circleLong-term Disability Leavecheck_circleDependent Daycare Spending Accountcheck_circleTuition Assistance/Reimbursementcheck_circleSimple Steps Global Well-being Programcheck_circle401(k) Plan with Employer Contribution and Matchcheck_circleShort-term Disability
Medtronic logo
Company

Medtronic

Industry

engineering

View company profilearrow_forwardlanguageWebsite
Quick Overview

Experience

4+ yrs (Senior)

Education

Baccalaureate degree required

Job Type

Full-Time

Skills Required

Quality Management SystemMedical Device Change Management510(k)PmaEu's Medical Device RegulationMDR
arrow_forward
Is this Senior Regulatory Affairs Specialist - Onsite job remote, hybrid, or on-site?expand_more
Medtronic has listed this Senior Regulatory Affairs Specialist - Onsite role as on-site.
How much experience is required for this Senior Regulatory Affairs Specialist - Onsite role?expand_more
Senior Regulatory Affairs Specialist - Onsite at Medtronic typically requires 4+ years of relevant experience at the senior level.
What skills do you need for the Senior Regulatory Affairs Specialist - Onsite role at Medtronic?expand_more
Key skills for Senior Regulatory Affairs Specialist - Onsite at Medtronic include Quality Management System; Medical Device Change Management; 510(k); Pma; Eu's Medical Device Regulation; and MDR.
What education is required for Senior Regulatory Affairs Specialist - Onsite at Medtronic?expand_more
Educational requirements for this role: Baccalaureate degree required.
What category does the Senior Regulatory Affairs Specialist - Onsite role belong to?expand_more
Senior Regulatory Affairs Specialist - Onsite at Medtronic is part of the engineering job category on Recrutus.
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Recrutus helps candidates discover roles that match their skills and helps teams reach qualified applicants faster. Browse by metro, discipline, or work style — from internships to senior leadership.

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