Manager, MDR & Vigilance

Inspire Medical Systems Inc.•Minneapolis, MN

1d•$106,000 - $145,000•Onsite

About The Position

Inspire Medical Systems is revolutionizing the sleep industry with its FDA-approved medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). The Manager, MDR & Vigilance is responsible for leading post-market surveillance and vigilance activities, including complaint evaluation, reportability assessments, regulatory reporting, team oversight, and process management. This role partners closely with Quality, Regulatory, Clinical, Medical Affairs, Reliability, and Operations to support timely and compliant reporting to regulatory authorities and strengthen the overall post-market surveillance program. The role provides direct leadership for the MDR and Vigilance team, manages daily priorities and resources, supports team development, and ensures the function operates effectively, consistently, and in compliance with global reporting requirements.

Requirements

Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field.
7+ years of experience in medical device quality, complaint handling, MDR reporting, or vigilance activities.
Strong knowledge of FDA MDR, EU MDR Vigilance, and global adverse event reporting regulations.
Experience managing cross-functional initiatives and operational processes.
Strong analytical, communication, and organizational skills.

Nice To Haves

Previous leadership, supervisory, or team lead experience preferred.

Responsibilities

Lead the MDR and Vigilance team, including day-to-day direction, workload prioritization, coaching, performance feedback, and employee development.
Set team expectations, monitor progress against reporting timelines, and address barriers that could impact compliance, quality, or turnaround time.
Oversee evaluation and assessment of product complaints to determine global reportability requirements and ensure timely regulatory submissions.
Manage day-to-day post-market surveillance operations and ensure compliance with FDA, EU MDR, and other applicable global vigilance regulations.
Develop, maintain, and enhance vigilance procedures, work instructions, metrics, and compliance monitoring processes.
Allocate resources and establish priorities to meet reporting timelines, departmental objectives, and regulatory requirements.
Make decisions on workload balancing, issue escalation, and team support to keep daily vigilance activities moving effectively.
Partner with Regulatory Affairs, Clinical, Reliability, Medical Affairs, and Quality teams to support investigations and regulatory reporting activities.
Monitor reporting trends, identify compliance risks, and implement corrective actions and process improvements.
Serve as the primary escalation point for complex complaint investigations, reportability assessments, and cross-functional alignment needs.
Drive operational initiatives focused on process efficiency, quality improvements, automation, and reporting effectiveness.
Prepare and communicate performance metrics, compliance updates, and recommendations to Quality leadership.
Support regulatory inspections, audits, and responses to health authority inquiries related to vigilance activities.
Manage external stakeholder communications and requests related to adverse event reporting and complaint investigations.
Ensure team training, competency assessments, and compliance with Quality System requirements.
Build team capability through training, coaching, clear guidance, and ongoing support in complaint evaluation, reportability assessments, and global reporting expectations.
Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
Complete training requirements and competency confirmations as required for this position within the required timeline.
Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
Ensure all direct reports maintain training records that comply with applicable quality system requirements.