Product Monitoring Manager

Job 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.
• Cook up 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.

Job Requirements

• 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)