Customer Quality Regulatory Inquiry Manager

Medtronic

Customer Quality Regulatory Inquiry Manager leading post-market regulatory responses at Medtronic, a global healthcare technology company. Managing a seven-person team and improving inquiry operations, metrics, and compliance.

Posted 9/2/2026full-timeMounds View • Colorado, Minnesota • 🇺🇸 United StatesMid-LevelSenior💰 $113,600 - $170,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing regulatory inquiries and leading cross-functional teams within a regulated healthcare environment. Proficient in process improvement, operational performance metrics, and effective communication with executive leadership.

Highest-signal resume keywords

Regulatory Affairs ManagementTeam LeadershipFDA KnowledgeLean Six Sigma Black BeltProcess Improvement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ReportingPost-Market SurveillanceComplaint HandlingWorkflow OptimizationProcess Automation

Soft Skills

Strong Written CommunicationVerbal CommunicationPresentation SkillsStakeholder Management

Tools & Technologies

MetricsDashboardsReporting Mechanisms

Certifications & Qualifications

Lean Six Sigma Black Belt

Industry Keywords

Medical Device QualityGlobal Regulatory RequirementsEU MDRCross-Functional CollaborationRegulated Environment

About the role

Key responsibilities & impact

Lead a team responsible for coordinating and delivering timely, accurate, and well-supported responses to global regulatory authority inquiries related to post-market quality activities
Establish and mature the operating model for a newly consolidated team
Lead approximately seven professionals
Build team capability, drive role clarity, strengthen execution discipline, and improve timeliness and quality of regulatory responses
Coordinate cross-functional collaboration with Regulatory Affairs, Legal, Quality, and business-unit subject-matter experts
Communicate performance, risks, trends, and improvement priorities to senior and executive leadership
Directly manage professionals through goal setting, performance expectations, work assignment and balancing, employee leveling, performance reviews, coaching, and improvement plans
Establish, implement, and continuously improve a standardized end-to-end regulatory inquiry operating model
Drive operational performance using metrics, dashboards, and reporting mechanisms
Own and evaluate existing processes and implement process improvement initiatives
Organize, lead, and facilitate cross-functional teams and meetings
Communicate team progress, including executive leader communications and presentations

Requirements

What you’ll need

Bachelor’s degree and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years of prior relevant experience
Minimum of 2 years of prior experience supervising or managing others
Experience managing new or growing teams
Knowledge of FDA, EU MDR, and other global regulatory requirements
Relevant experience in medical device quality, regulatory affairs, post-market surveillance, complaint handling, regulatory reporting, field corrective actions, or related regulated healthcare or life-sciences environment
Demonstrated experience leading cross-functional work in a regulated environment
Demonstrated experience managing complex work to defined timelines, including issue escalation and stakeholder coordination
Strong written communication skills, including clear, concise, evidence-based technical or regulatory communications
Strong verbal communication, presentation, and stakeholder-management skills
Knowledge of Lean Six Sigma Black Belt or similar methodologies
Ability to deliver executive-level presentations and communicate complex topics effectively
Experience implementing process automation, workflow optimization, and technology solutions
For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
Roles below the Principal level require unrestricted U.S. work authorization at the time of hire and for the duration of employment

Benefits

Comp & perks

Competitive salary and flexible Benefits Package
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
Capital Accumulation Plan for Vice Presidents and above, or subject to IRS earning minimums
Temporary employees eligible for paid sick time as required under applicable state law and Employee Stock Purchase Plan
Potential of 10% travel