Regulatory Affairs Director

Regulatory Affairs DirectorCareers 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.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 responsibilitiesDirect 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 responsibilitiesProvide 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 impactLead 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 RequirementsTo be considered for this role, please ensure the minimum requirements are evident in your applicant profile.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.Nice To HaveExperience 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 teamsFor 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 RequirementsThe 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 & SponsorshipAt Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. 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.Recruitment Fraud AlertWe 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 @medtronic.com 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 View email address on click.appcast.io & CompensationMedtronic 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):$194,400.00 - $291,600.00This 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 insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement