Senior Regulatory Affairs Manager

Medtronic

Senior Regulatory Affairs Manager leading product release strategy and team at Medtronic. Ensuring compliance with global regulatory requirements and driving process improvements in healthcare technology.

Posted 6/24/2026full-timeMinneapolis • Colorado, Florida, Minnesota, Tennessee, Texas • 🇺🇸 United StatesSenior💰 $154,400 - $231,600 per yearWebsite

About the role

Key responsibilities & impact

Lead and develop a high-performing team focused on product release and regulatory execution
Lead end-to-end regulatory product release strategy and execution, ensuring compliance with global regulatory requirements
Drive process standardization, simplification, and automation across product release workflows
Lead data quality initiatives to support compliant global submissions and product distribution
Oversee regulatory distribution control processes (e.g., GTS/SAP) to enable timely and accurate product release
Lead continuous improvement initiatives focused on cycle time, quality, and scalability of release processes
Establish and monitor KPIs, dashboards, and reporting to track performance and compliance
Build organizational capability in regulatory systems, data, and operational execution

Requirements

What you’ll need

Bachelor’s degree
7+ years of experience supporting or leading product release, distribution control, or regulatory operations processes (or 5+ years with advanced degree)
5+ years of managerial experience
Strong knowledge of global regulatory requirements impacting product distribution (FDA, EU MDR, international markets)
Organizational skills and highly detail oriented
Intermediate knowledge of spreadsheet and database applications (Microsoft Office, and SharePoint)
Analytical and problem-solving skills
Effective project management skills
Experience with GTS/SAP, UDI (GUDID/EUDAMED), and/or RIM systems
Experience in regulatory data management, governance, or digital transformation
Experience driving process harmonization across global organizations
Proven ability to work in complex, matrixed organizations and influence stakeholders
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.

Benefits

Comp & perks

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)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory product releaseregulatory operationsdata quality initiativesprocess standardizationprocess automationKPI monitoringregulatory data managementdigital transformationproject managementanalytical skills

Soft Skills

organizational skillsdetail orientedproblem-solving skillsinfluencing stakeholdersleadershipteam developmentcontinuous improvementcommunication skillscapability buildingperformance tracking