Regulatory Affairs Director

We anticipate the application window for this opening will close on - 9 Oct 2026

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 95000 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.

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 -person exchanges are invaluable to our work. Were 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 Managers 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

To be considered for this role please ensure the minimum requirements are evident in your applicant profile.

• Bachelors 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.

Nice To Have

• 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

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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful 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.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.

If you receive a suspicious message claiming to be from Medtronic do not respond click links or open attachments.

If you have any questions concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic please contact us immediately at .

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$194400.00 - $291600.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

This position is eligible for an annual long-term incentive plan.

The base salary range is applicable across the United States excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience certification/education market conditions and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic Inc. (Medtronic) 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 you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. 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.