Regulatory Affairs Director

Medtronic; Mounds View (MN); Vor Ort; USD 180.000 - 230.000; Vollzeit

Zusammenfassung

Medtronic in Mounds View, MN seeks a Regulatory Affairs Director to lead regulatory strategy and execution across CDS and PCS in the Electrophysiology Therapies unit. You will direct regulatory submissions, audits, and inspections, and shape strategies aligning with business goals.

The role requires deep regulatory expertise, strong leadership skills, and ability to influence cross-functional teams to achieve timely approvals and compliant outcomes.

Qualifikationen

• Bachelor's degree required in a relevant field.
• 10+ years of medical device regulatory affairs experience, including 7+ years of managerial experience.
• An advanced degree with 8+ years of regulatory affairs experience is acceptable.

Aufgaben

• Direct regulatory strategy and execution across CDS/PCS in the EPT OU.
• Lead regulatory submission activities, audits, and inspections.
• Influence cross-functional stakeholders to achieve timely regulatory outcomes.

Kenntnisse

Regulatory leadership

Strategic planning

Cross-functional leadership

Regulatory submissions

Ausbildung

Bachelor's degree

Advanced degree (preferred)

Jobbeschreibung

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.

A Day in the Life

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.

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.

Key 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.

Leadership responsibilities

• 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.
• Authorize hiring, promotion, reward, and other people decisions within the area of responsibility.

Scope and impact

• 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.

Must Have; Minimum 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 o