Manager, Post Market Surveillance

About the Company

Inspire is the first-of-its-kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation, prioritizing patient outcomes, acting with integrity, and leading with respect. With positive persistence at our core, we are dedicated to serving all stakeholders.

At Inspire, we value diverse experiences, backgrounds, and perspectives. We foster a people-first culture that encourages learning, community-building, and professional growth.

About the Role

This position provides leadership and subject-matter expertise in global complaint-handling quality system requirements and regulations. The role manages complaint initiation, preliminary complaint investigation, call center and investigator staffing, and complaint-handling training. It also oversees process monitoring, trending, and reporting. The individual will collaborate closely with cross-functional teams to ensure timely processing of complaints and related support activities.

The ideal candidate thrives in a fast-paced, dynamic environment, demonstrates strong teamwork and communication skills, and operates with a high level of initiative.

Responsibilities

• Manage the incoming complaint and product report process, preliminary complaint investigations, and provide expertise on global complaint-handling requirements for finished medical devices.
• Lead a team of post-market call center representatives and specialists (investigators), providing coaching, feedback, and development.
• Manage staffing across multiple shifts to ensure required coverage, including performing call handling and investigation activities as needed.
• Monitor and review incoming calls and documented complaints for completeness, accuracy, and compliance.
• Deliver performance reporting on key quality processes and metrics to support compliance monitoring and continuous improvement.
• Mentor and coach the team on medical device QMS requirements and best practices to achieve “best-in-class” performance and process throughput.
• Ensure quality and regulatory compliance in accordance with internal and external quality systems and standards.
• Recruit top candidates for post-market surveillance positions and ensure proper training for new hires and contractors.
• Manage the complaint and product reporting process for non-Inspire medical devices, Inspire clinical devices, and non-medical software applications.
• Support medical device and vigilance reporting, returned product evaluations, and complaint closure teams.
• Manage special projects and product improvement processes as directed by quality management.

Quality System Responsibilities

• Document product and therapy-related field reports within prescribed timelines and provide necessary documentation to complete investigations.
• Provide follow-up reporting as needed.
• Complete training requirements and competency confirmations within the required timeline.
• Comply with applicable quality system procedures and policies, and suggest improvements for continuous process enhancement.
• Ensure all direct reports maintain training records compliant with quality system requirements.

Requirements

• Bachelor’s degree in a technical or scientific field, or a Bachelor’s degree in any discipline with a minimum of 8 years of experience in implantable medical devices.
• Minimum of 5–10 years of experience in the medical device industry.
• Minimum of 5 years of experience managing teams with customer-facing responsibilities.
• Demonstrated team leadership skills and ability to prioritize, execute, and report on projects.
• Extensive knowledge of complaint-handling requirements for ISO, FDA, and European Medical Device Regulations/QMS (e.g., ISO 13485; 21 CFR Part 820.198, 820).
• Strong interpersonal, verbal, and written communication skills, with the ability to facilitate teams and deliver presentations.
• Experience supporting external regulatory audits.
• Strong project and time management skills, with the ability to handle multiple tasks and shifting priorities.
• Proficiency in MS Word, Excel, Outlook, and PowerPoint.

Preferred Qualifications

• Bachelor’s degree in engineering, nursing, or another medical field; Master’s degree in a technical or scientific field.
• Experience with Class III active implantable medical devices.
• Clinical experience in nursing, sleep, or another medical discipline.
• Front-room experience supporting external regulatory audits.
• Advanced Excel reporting and SQL skills.
• Internal auditor training or certification.

Pay

Salary range: $106,000—$145,000 USD. The final compensation will be determined based on factors such as geographic location, work experience, education, and skill level.

Benefits

• Multiple health insurance plan options with employer contributions to a Health Savings Account.
• Dental, vision, life, and disability benefits.
• 401k plan with employer match.
• Identity protection.
• Flexible time off (FTO).
• Tuition reimbursement.
• Employee Assistance Program.
• Opportunity to participate in equity awards and the Employee Stock Purchase Program (ESPP).