Regulatory Affairs Director

Medtronic•Mounds View, MN

2d•Hybrid

About The Position

Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. This position will be based in Mounds View, MN. Medtronic is seeking a Regulatory Affairs Director to lead regulatory strategy and execution across Cardiovascular Diagnostics & Services (CDS) and Patient Care Services (PCS) in the Electrophysiology Therapies (EPT) Operating Unit (OU). This role is responsible for directing regulatory submission activities, supporting compliance initiatives, and leading regulatory interactions tied to global approvals, registrations, audits, and inspections. The role combines deep regulatory expertise with strong people leadership. This leader will support and guide regulatory matters for the General Manager’s team in CDS, the EPT staff member who leads PCS, as well as influence cross-functional stakeholders, and help shape strategies that support timely regulatory outcomes and business objectives. The Electro Physiology Technologies business unit is focused on advancing innovative solutions that support the diagnosis and treatment of cardiac rhythm disorders. The team works collaboratively to develop, deliver, and improve technologies that help clinicians provide effective patient care. Operating in a fast-paced, highly regulated environment, the business unit emphasizes quality, innovation, cross-functional partnership, and continuous improvement to support both customer needs and long-term business success. 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.

Requirements

Bachelor’s degree required.
Typically requires 10+ years of medical device regulatory affairs experience, including 7+ years of managerial experience.
Or an advanced degree with 8+ years of medical device regulatory affairs experience, including 7+ years of managerial 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 is required for roles below Principal level.

Nice To Haves

Experience innovating regulatory strategies for new spaces, and influencing stakeholders across functions.
Experience navigating complex regulatory environments.
Ability to guide regulatory strategy while developing talent and driving execution.
Broad management and leadership knowledge to lead multiple job areas.
Detailed functional and operational expertise.
Strong ability to work independently and perform without appreciable direction.
Demonstrated experience managing teams.

Responsibilities

Direct or perform coordination and preparation of document packages for regulatory submissions for CDS/PCS, internal audits, and inspections.
Lead or compile all materials required in submissions, license renewals, and annual registrations.
Recommend changes for labeling (indications), manufacturing, marketing, and clinical protocol to support regulatory compliance.
Monitor and improve tracking and control systems.
Keep abreast of regulatory procedures and changes.
Direct interaction with regulatory agencies on defined matters, as applicable.
Recommend strategies for the earliest possible clearance or approval of hardware devices and software as a medical device.
Provide motivational leadership for the team.
Provide thought and technical leadership to all areas of the business.
Drive continuous improvement initiatives through creative problem solving, process innovation, and executive sponsorship.
Manage performance, employee development, and departmental priorities through direct and/or indirect reports.
Determine supervisory relationships and create strategic workforce staffing plans to achieve business results.
Authorise hiring, promotion, reward, and other people decisions within the area of responsibility.
Lead the development of strategy for the CDS/PCS teams and ensure alignment to company aims and objectives.
Make large business decisions and some strategic decisions within the function.
Influence outcomes that may affect financial performance, employees, or the public image of the operational unit and/or company.
Drive innovation across the business area and encourage best practice and knowledge sharing.
Improve, adapt, or change processes, systems, products, or services within the department or business area.
Address complex, difficult, and undefined issues that require detailed information gathering, analysis, and investigation.
Develop long-term strategic relationships and alliances with key internal and external stakeholders.
Communicate and conduct briefings with senior or executive leadership regarding ongoing operations and strategic initiatives.
Influence across functions and businesses to negotiate and gain cooperation on operational issues and internal divergent objectives.

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)