Customer Quality Regulatory Inquiry Manager

Customer Quality Regulatory Inquiry Manager

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

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.

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 role has the potential of 10% travel.

Primary 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.

Required Qualifications:

• 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.

Preferred Qualifications:

• 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…