Regulatory Affairs Director

MED Medtronic Inc; Mounds View (MN); On-site; USD 194,000 - 292,000; Full time

Job summary

Medtronic is seeking a seasoned regulatory affairs leader to drive the CDS/PCS program, coordinate submissions, and interact with regulators. You will guide labeling, compliance, and lifecycle management while shaping strategy across multiple functions.

The role emphasizes leadership, governance, and collaboration with senior leadership to advance regulatory clearance and ensure alignment with company objectives.

Qualifications

• 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.

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.
• Authorize 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.

Job description

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.

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 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.

Nice To Have Experience

• 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.

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 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.

Benefits & Compensation

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):$194,400.00 - $291,600.00 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 pertaining 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, and Simple 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 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), and Capital 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

Equal Employment Opportunity (EEO)

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 law. In 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 find here 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.

Health Care and Safety

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life‑changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need. Life‑transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance ...

Sales Channels & E-Verify

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.