Regulatory Workstream Lead – Product DNA

Medtronic•Memphis, TN

1d•$154,400 - $231,600•Onsite

About The Position

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.

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 Haves

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.

Responsibilities

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.

Benefits

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
Simple Steps (global well-being program)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)