Manager, Post Market Surveillance

Inspire Medical Systems - Minneapolis, MN

Hiring: Manager, Post Market Surveillance Company: Inspire Medical Systems Location: Minneapolis, MN Job Posted Time: 2026-09-16 22:22:51 Target Skills & Keywords : Microsoft Excel, Microsoft PowerPoint, Regulatory Compliance, SQL About the job Experience: •Minimum 5 – 10 years’ experience in the medical device industry. •Minimum 5 years’ experience in managing teams with customer facing responsibilities. •Demonstrated team leadership skills and ability to prioritize, execute and report on projects •Extensive knowledge on complaint handing requirements for ISO, FDA and European Medical Device Regulations/QMS Requirements (e.g. ISO 13485; 21 CFR Part 820.198, 820) •Effective relationship management, ability to network, support and influence across the entire organization. Required Skills: •Manage the incoming complaint/product report process, the preliminary complaint investigation process and provide expertise 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 multiple shifts to ensure required coverage is met. •Perform call handling and investigation activities as needed to support the team. •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 initiatives. •Perform, support, mentor, and coach team on medical device QMS requirements and best practices for achieving “best in class” performance and process throughput. •Ensure that the quality and regulatory compliance is maintained in accordance with both Internal and external quality systems and standards. Qualifications: •Bachelor’s degree in a technical or scientific field or Bachelor’s degree in any discipline with a minimum of 8 years experience in implantable medical devices •Bachelor’s degree in an engineering, nursing or other medical field. •Master’s degree in a technical or scientific field. •Clinical experience in nursing, sleep or other medical discipline •Front room experience supporting external regulatory audits •Advanced computer skills with Excel reporting and SQL •Internal auditor training or certification Compensation: •$106,000 - $145,000 / year •Competitive benefits and rewards package •Multiple health insurance plan options Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!