Senior Regulatory Affairs Specialist- Structural Heart

Medtronic•Mounds View, MN

12d•Onsite

About The Position

We anticipate the application window for this opening will close on - 2 Jan 2026 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. A Day in the Life The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta. 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. This position will be based in Mounds View, MN or Santa Rosa, CA. The Senior Regulatory Affairs Specialist will support our innovative Transcatheter Tricuspid Valve Therapy to treat tricuspid valve disease. This role is responsible for developing strategies for worldwide governmental approval to introduce new products (Class II and Class III) to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with the agencies. The Sr Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. This position will support worldwide regulatory activities associated with the innovative transcatheter tricuspid valve therapy to treat tricuspid valve disease. This position will provide an opportunity to work on a new product development project for a Class III device that seeks to address an unmet need for patients. 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 are working onsite 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Requirements

Bachelor’s degree required with a Minimum of 4 years of experience in medical device regulatory affairs experience
Or Advanced degree with 2 years of experience

Nice To Haves

Advanced degree in a scientific discipline (engineering, physical/biological or health sciences)
Experience with heart valve products
Experience with Software as a Medical Device
RAC Medical Device Certification
Experience with Class II/III (510(k), PMA, IDE) and EU MDR medical device submissions
Experience with assessment and reporting of product changes according to US and EU regulatory requirements
Product development experience
Clinical or statistical experience
Experience with FDA and international regulatory agency requirements, ISO/GHTF standards
Ability to comprehend principles of engineering, physiology and medical device use
Excellent communication, negotiation, and problem-solving skills.
Effective interpersonal skills and team member
Ability to effectively manage multiple projects and priorities in a fast-paced environment
Detail oriented
Proficient computer skills

Responsibilities

Team with operating unit Regulatory Affairs Specialists and international regulatory staff to develop and execute regulatory strategies for new and existing products, ensuring alignment with business objectives and regulatory requirements.
Collaborate with R&D, Quality, Clinical, and Marketing teams to ensure regulatory compliance throughout the product development process and to resolve potential regulatory issues and questions from regulatory agencies.
Prepare regulatory documentation for new products, product changes, audits, as required, to ensure timely approvals and compliance for clinical studies and market release.
Review significant product submissions with manager and negotiate submission issues with agency personnel.
Assist in negotiations with FDA and/or international regulatory agencies on assigned projects/products.
Support regulatory compliance activities, including manufacturing site registration, audits, annual reporting, as needed.
Monitor and analyze regulatory trends and changes, providing strategic guidance to cross-functional teams.
Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.
Ensure personal understanding of all quality policy/system items that are personally applicable.
Follow all work/quality procedures to ensure quality system compliance and high-quality work.
Maintain regulatory documentation to ensure compliance.
Manage multiple projects, prioritize daily tasks, and ensure project deadlines are met.
Contribute to continuous improvement and process optimization initiatives within the department.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
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)