Customer Quality Regulatory Inquiry Manager

Medtronic • Lafayette, MN

68d • Hybrid

About The Position

The Customer Quality Regulatory Inquiry Manager will 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. Inquiries may include matters associated with complaint handling, regulatory reporting, field corrective actions, and other post-market quality processes. This role will establish and mature the operating model for a newly consolidated team, ensuring effective intake, prioritization, assignment, escalation, review, and tracking of regulatory inquiries. The manager will lead a team of approximately seven professionals and will be accountable for building team capability, driving role clarity, strengthening execution discipline, and improving timeliness and quality of regulatory responses. The role requires strong knowledge of medical device post-market quality systems and the ability to lead cross-functional collaboration with Regulatory Affairs, Legal, Quality, and business-unit subject-matter experts. The manager will communicate performance, risks, trends, and improvement priorities to senior and executive leadership.

Requirements

• Requires a Bachelor’s degree and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years of prior relevant experience.

Nice To Haves

• Requires a minimum of 2 years of prior experience supervising or managing others and 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 the ability to develop clear, concise, and evidence-based technical or regulatory communications.
• Strong verbal communication, presentation, and stakeholder-management skills.
• Knowledge of Lean Six Sigma Black Belt or similar methodologies to drive continuous improvement.
• Ability to executive-level presentations and communicate complex topics effectively.
• Experience Implementing process automation, workflow optimization, and technology solutions.

Responsibilities

• Directly Manage Professionals, including but not limited to: Goal setting, Establishing measurable performance expectations, Assigning and balancing work, Assessing employee leveling, Conducting Performance Reviews, On-going assessment, and response when needed for personnel management through coaching, improvement plans, etc.
• Establish, implement, and continuously improve a standardized end-to-end operating model for regulatory inquiries, including intake, risk-based prioritization, assignment, response development, review, approval, submission, escalation, and closure
• Drive operational performance through the development and use of meaningful metrics, dashboards, and reporting mechanisms, including inquiry volume, aging, on-time response performance, cycle time, response quality, workload capacity, and recurring inquiry trends.
• Own and evaluate existing processes; and plan and implement process improvement initiatives.
• Organize, lead and facilitate cross-functional teams and team meetings.
• Communicate team progress, including executive leader communication, and presentations.

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal