Sr Program Manager – Global MDR Program Lead
Lafayette, IN - USA
Job Summary
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
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. You will lead with purpose breaking down barriers to innovation in a more connected compassionate world.The Sr Program Manager leads one of the Surgical Operating Units most complex regulatory and operational programs responsible for enabling the EU MDR transition while maintaining global product availability.
The role provides direct leadership to a program team of four reports and orchestrates execution across regulatory supply chain operations quality clinical and commercial organizations. Success requires integrating regulatory transition plans global market access strategies and operational readiness to ensure continuity of product supply across international markets. The role also partners closely with supply chain and operations leaders to address complex operational challenges associated with regulatory transitions product lifecycle decisions and global supply continuity.
This leader operates at the center of decision-making guiding prioritization resolving cross-functional tradeoffs and ensuring the organization can navigate regulatory change without disruption to patients or customers.
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. We are working a minimum of four 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.
Program Scope
- Leads a complex regulatory transition program with global market and operational impact.
- Directly manages a team of program leaders responsible for key MDR transition workstreams.
- Integrates regulatory operational and commercial plans to ensure uninterrupted global product availability.
- Coordinates execution across Regulatory Affairs Supply Chain Operations Quality Marketing Clinical and enterprise PMO teams.
You will
- Program Strategy and Governance
- Define and implement the EU MDR program strategy and Globalization approach aligned with regulatory requirements and business priorities.
- Establish governance structures decision frameworks and operating mechanisms that enable effective program execution across multiple teams and regions.
- Drive integrated program planning that aligns regulatory transition activities market access planning and operational readiness.
- Ensure alignment across MDR program workstreams while maintaining clear accountability for execution and program outcomes.
- Partner with Supply Chain and Operations leadership to incorporate manufacturing supply and lifecycle considerations into MDR transition planning and program decision-making.
- People Leadership and Program Direction
- Lead and develop a team of program leaders responsible for key MDR transition workstreams establishing clear accountability and performance expectations.
- Coach and mentor team members to strengthen program leadership capability stakeholder engagement and strategic execution.
- Build and lead a cohesive program leadership team that collaborates effectively across workstreams and functions.
- Enable program team members to operate with autonomy while maintaining alignment with overall program strategy and priorities.
- Globalization and Product Continuity
- Lead the Globalization strategy aligning regulatory registrations market access planning and supply readiness across global regions.
- Integrate regulatory transition plans with manufacturing supply chain and commercial readiness to maintain uninterrupted product availability.
- Identify and mitigate regulatory and operational risks that could impact global market access or product supply.
- Drive cross-functional planning to ensure regulatory timelines product lifecycle decisions and supply strategies remain synchronized.
- Program Planning and Execution
- Develop and maintain integrated multi-year program plans including milestones dependencies and risk mitigation strategies across multiple workstreams.
- Monitor program progress and proactively address risks issues and constraints that may impact regulatory commitments or product availability.
- Provide clear recommendations on prioritization trade-offs and execution adjustments as conditions evolve.
- Drive disciplined program management practices that enable consistent execution and transparency across the organization.
- Resource and Financial Management
- Lead multi-year resource planning including staffing tools and operational capabilities required to support the MDR transition.
- Manage program budgets and track financial performance against program plans.
- Ensure resources are aligned with program priorities and evolving regulatory timelines.
- Stakeholder Engagement and Communication
- Partner with cross-functional leaders across Regulatory Affairs Supply Chain Operations Quality Marketing and Clinical teams to maintain alignment on program priorities and regulatory commitments.
- Facilitate decision-making across senior leadership by providing clear program insights recommendations and trade-off analysis.
- Provide consistent and transparent program reporting including dashboards key risks and executive updates.
- Performance and Continuous Improvement
- Define and monitor key performance indicators to assess program health execution effectiveness and readiness milestones.
- Identify opportunities to simplify processes improve scalability and strengthen program governance.
- Maintain awareness of evolving global regulatory requirements and industry best practices to ensure program readiness.
Must Have
- Bachelors degree with a minimum of 7 years of relevant experience
OR advanced degree with a minimum of 5 years of relevant experience - 5 years leading complex cross-functional programs in a matrixed environment
- 5 years managing multiple concurrent projects or programs of increasing complexity
- 5 years managing program budgets or financial tracking
- 5 years leading stakeholder communications across multiple organizational levels
- 5 years directly managing or mentoring project managers or program team members
- Experience working in the medical device life sciences or other regulated industry
- Experience supporting supply chain manufacturing or operational programs where regulatory product lifecycle or market access decisions impact product supply continuity.
- Demonstrated ability to build or scale programs from concept through execution
- Demonstrated experience building and developing high-performing program or project management teams.
- Ability to operate effectively in complex and evolving environments
Nice to Have
- PMP or PgMP certification
- Experience supporting EU MDR or other global regulatory transitions
- Experience with program planning tools such as Microsoft Project or ResourceFirst / PDWare
- Experience developing program dashboards and reporting using tools such as Power BI
- Experience partnering with technical teams to support automation or digital program management tools
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.
Join us in our mission to alleviate pain restore health and extend lifewhere your unique background and perspective are valued.
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.
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.
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.
Required Experience:
Manager
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more