We anticipate the application window for this opening will close on - 24 Jan 2026

At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

As a Senior Regulatory Affairs Program Manager you will be the strategic linchpin that drives operational excellence across the different arms of the RA function within the Acute Care & Monitoring (ACM) operating unit. Your day will be a dynamic mix of strategic planning and tactical execution. A significant portion of your day will involve facilitating program-level meetings with leadership where you will use your expertise to guide strategic discussions manage through risks and drive critical decisions to ensure the functional commitments are met. You will also dedicate time to analyzing and interpreting complex performance data balancing resource demand across the function managing the budget forecast relative to AOP and driving process/systems improvement initiatives. Your role is a blend of a forward-thinking strategist a hands-on problem-solver and a collaborative leader all working to ensure our regulatory affairs function operates at the highest level of efficiency and effectiveness.

Responsibilities May Include

• Operating Mechanisms:
  • Design implement and maintain advanced operating mechanisms to ensure seamless program execution and cross-functional alignment across all Regulatory Affairs programs.
  • Establish and facilitate program-level meetings with senior leadership and key stakeholders to track progress manage complex risks and drive critical business decisions.
  • Develop and manage comprehensive program calendars communication plans and high level stakeholder engagement strategies.
• Budget Management:
  • Develop and manage the functional budget including long-term forecasting tracking and reporting on expenditures.
  • Ensure the optimal allocation of financial resources to support critical program objectives and key initiatives.
  • Identify and implement significant cost reallocation opportunities without compromising quality or compliance.
• Process Improvement Initiatives:
  • Lead and champion large-scale high-impact process improvement initiatives aimed at enhancing the efficiency quality and effectiveness of regulatory operations.
• Resource Management:
  • Collaborate with RA leaders and other department heads to forecast long-term resource needs and ensure appropriate staffing levels for all programs.
  • Proactively identify and address complex resource constraints or conflicts to maintain project timelines and deliverable quality.
  • Optimize resource utilization across a portfolio of multiple projects and initiatives.
• Performance Metrics Development and Execution:
  • Develop define and implement key performance indicators (KPIs) and other sophisticated metrics to measure the success and efficiency of regulatory programs.
  • Establish high level dashboards and reporting mechanisms to provide senior stakeholders with clear visibility into performance.
  • Analyze complex performance data to identify strategic trends opportunities for improvement and areas of risk.
• Integration of Enterprise Initiatives:
  • Act as the primary liaison between the RA function and enterprise-level program initiatives.
  • Ensure the seamless integration of enterprise-level initiatives (e.g. new technology platforms corporate compliance programs) into the ACM RA function.
  • Communicate enterprise-level changes to the team and manage the associated change management activities.
• Other Business Initiatives:
  • Provide expert program management leadership for ad-hoc projects special assignments and new ventures.

Differentiating Factors

• Experience with large-scale enterprise-level initiatives: A background in integrating entire business units into broader corporate programs.
• Subject Matter Expertise: Deep knowledge of specific regulatory domains (e.g. global submissions post-market surveillance quality systems). Experience implementing initiatives through effective influence management skills at multiple levels in the organization with a general understanding of medical device regulations and submissions.
• Technical Proficiency: Experience with regulatory information management systems (RIMS) project management software (e.g. Smartsheet MS Project) and data visualization tools (e.g. MS Excel Power BI).
• Change Management: Demonstrated ability to lead and manage large-scale organizational change effectively.

Program Management Career Stream

This role is a key position within the program management career stream offering significant growth opportunities. Successful performance in this role can lead to senior portfolio management positions or executive leadership roles within Regulatory Operations or other business functions. The ideal candidate will be a strategic and visionary thinker with a proven track record of driving complex enterprise-level initiatives to successful completion and a desire to continuously elevate their skills and responsibilities.

Minimum Requirements:

Bachelors degree and 7 years of regulatory program management experience or advanced degree with 5 years of regulatory program management experience.

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.

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):$154400.00 - $231600.00

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

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

About Medtronic

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 95000 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.

Learn more about our business mission and our commitment to diversity here.

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.