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

A Day in the Life

At Medtronic, we are committed to engineering the extraordinary. The Product DNA Program is a cornerstone of our digital transformation, enabling a connected digital thread of product data across the product lifecycle.

As the Regulatory Workstream Lead – Product DNA, you will play a critical leadership role in one of Medtronic’s most significant enterprise transformation initiatives. The Product DNA program is a multi-year effort to establish a connected, non-transactional thread of product data across the full product lifecycle, enabling improved collaboration, efficiency, and regulatory compliance across Medtronic’s global ecosystem, including PLM, MES, and ERP platforms.

Reporting to the Sr. Director, Product DNA Implementation Lead within Global Technology & Innovation, you will lead the Regulatory workstream and partner closely with Regulatory leadership and cross-functional stakeholders. Your work will directly support Medtronic’s Mission by enabling scalable, compliant, and future-ready product data capabilities that help deliver safe, effective medical technologies to patients around the world.

We must work with a sense of purpose and ownership, knowing there is a human life on the other side of every decision.

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 is on-site, 4+ days/week at Memphis Pyramid.

         

         

We are seeking a leader with strong regulatory expertise, program leadership capability, and a passion for digital transformation in regulated environments—someone who thrives in ambiguity, values diverse perspectives, and can drive enterprise change through influence and collaboration.

As the Regulatory Workstream Lead – Product DNA, you will lead the Regulatory workstream for the Product DNA program and be accountable for strategy, execution, and outcomes across the enterprise.

Responsibilities include:

• Serve as the functional and process owner for the Regulatory workstream, driving day-to-day activities, priorities, and deliverables.

• Lead requirements gathering and business process design, defining regulatory data flows and data models that enable efficiency, scalability, and compliance.

• Partner with Regulatory leadership to define and execute the Regulatory strategy aligned with Product DNA objectives and enterprise priorities.

• Integrate Product DNA plans with broader Regulatory initiatives, roadmaps, and operating models.

• Manage scope interdependencies with other Product DNA workstreams and governed enterprise programs.

• Own workstream performance, including risk identification, mitigation strategies, and issue resolution.

• Define, track, and report key performance indicators (KPIs), including scope, cost, benefits, and return on investment.

• Lead and participate in cross-functional teams to structure complex issues, perform analyses, evaluate options, and develop recommendations related to regulatory processes, data, and systems.

• Identify, engage, and coordinate subject matter experts (SMEs) across functions and regions.

• Partner with SMEs and Organizational Change Management (OCM) teams on stakeholder engagement, change impact assessments, training strategies, and user adoption.

• Define acceptance criteria and develop test scripts for usability pilots and user acceptance testing (UAT).

• Monitor progress against milestones to ensure delivery on time, within budget, and to defined quality standards.

• Collaborate with solution architects and technical teams to inform development sequencing and design decisions.

• Participate in release planning, sprint and iteration planning, demonstrations, and increment reviews.

• Support feature integration and testing, verifying delivered user stories against sprint and program goals.

• Act as a Product DNA champion, promoting engagement and adoption across the Regulatory and end-user communities.

Must Have: Minimum Requirements

• Bachelor’s degree required.

• Minimum of 7 years of progressive experience in Regulatory Affairs or Regulatory Operations within the medical device or regulated healthcare industry with 5+ years of managerial experience; OR advanced degree with a minimum of 5 years of progressive experience in Regulatory Affairs or Regulatory Operations within the medical device or regulated healthcare industry with 5+ years of managerial experience.

• Demonstrated experience leading enterprise-scale, cross-functional programs or workstreams, preferably involving regulatory data, processes, and systems.

• Hands-on experience operating in FDA- and ISO-regulated environments, including global regulatory submissions and product lifecycle management activities.

• Proven ability to translate regulatory requirements into structured, scalable processes and data models that support enterprise systems and digital transformation initiatives.

Nice to Have

• Master’s degree (e.g., MBA, MS, or equivalent).

• PMP certification or equivalent program or project management credential.

• Experience managing and developing teams within Regulatory Affairs or Regulatory Operations.

• Strong background in regulatory data governance, analytics, and process optimization or automation.

• Experience supporting or implementing enterprise platforms such as PLM, ERP, or MES within a regulated environment.

• Deep familiarity with global regulatory frameworks and submissions, including but not limited to FDA (Q-Sub, 510(k), PMA, UDI/FURLS), EU MDR/CE Marking, and other international regulatory authorities.

• Understanding of the evolution toward digital and automated regulatory submissions and the implications for regulatory data strategy and system design.

• Experience integrating regulatory requirements into product lifecycle management, change control, and global trade or licensing processes.

• Excellent stakeholder engagement, facilitation, and executive communication skills, with the ability to influence at multiple organizational levels.

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 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.

Join us in our mission to alleviate pain, restore health, and extend life—where 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.
 

Salary ranges for U.S (excl. PR) locations (USD):$154,400.00 - $231,600.00

 

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. Base pay is based on numerous factors and may vary by job-related knowledge, skills, experience, etc. 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, 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

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 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.

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