Product Monitoring Manager

The Product Monitoring Manager will oversee product complaints and post-market surveillance in accordance with ISO 13485:2016, MDSAP, EU MDR, and other pertinent regulations. Success in this role requires strong leadership and comprehensive technical expertise in medical devices and pharmaceuticals. The Manager supervises a team and ensures sufficient resources are available to fulfill complaint handling and post-market surveillance-related responsibilities. Provide leadership in complaint handling and post-market surveillance processes. Ensure complaints are accurate and closed in a timely manner. Develop and monitor Key Performance Indicators (KPIs), reporting on the performance of complaint handling and post-market surveillance to executive management through Quality System Management Reviews. Perform trend analyses and lead monthly Product Performance Management (PPM) meetings. Provide oversight and review of device Vigilance Reports for the US, Canada, Australia, and/or Europe. Coordinate responses to regulatory agencies as required. Oversee Post Market Surveillance activities, ensuring complaints, vigilance, and annual reports (such as PSUR) comply with regulations and standard procedures. Compile and deliver comprehensive reports on product performance as needed. Support Health Hazard Evaluations (HHEs). Act as Subject Matter Expert (SME) for Complaint handling and post-market surveillance during audits and regulatory inspections. Lead periodic reviews of regulatory intelligence information to ensure procedures are updated. Complete literature reviews as necessary, reviewing to determine related complaints or adverse events. Maintain listing of weekly reviews in compliance with regulations. Supervise product monitoring analysts. Skills: Knowledge of data analytics using Excel and Minitab (statistical process control charts (SPC), decision trees) Knowledge of regulations and standards as they apply to complaint management and post-market surveillance Ability to read technical and medical documentation such as journal articles Leadership and cross-functional team development Strong communication and presentation skills Leads and mentors the Quality Systems and Complaint Teams Experience: 10+ years of experience in Quality-related field, with at least 5 years in managing complaint handling and post-market surveillance Strong knowledge of QSR/GMP (21 CFR Part 210, 211, 820) regulations, ISO/EU regulations/Standards (ISO 13485, EU MDR, MDSAP). Familiarity with other International Standards such as those for EMEA, TGA, PMDA, Health Canada, and other medical and pharmaceutical regulations. Education: • Bachelor’s degree in Life Sciences or a related technical field Job Benefits: Medical, Dental, Vision Insurance Life/AD&D Short- and Long-Term Disability 401(K) with large company match Health Saving Account (HSA) and Flexible Spending Account (FSA) with company match Wellness Program Employee Assistance Program (EAP) Generous Paid Time Off (PTO) Disclaimer: The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.