[Remote] Product Monitoring Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Product Monitoring Manager to reputed company product complaints and post-market surveillance in compliance with relevant regulations. The role requires strong leadership and technical expertise in medical devices and pharmaceuticals, with responsibilities including managing reputed company and ensuring effective complaint handling processes.

Responsibilities

• reputed company leadership in complaint handling and post-market surveillance processes
• Ensure complaints are accurate and reputed company in a reputed company manner
• reputed company and monitor Key Performance Indicators (KPIs), reporting on the performance of complaint handling and post-market surveillance to executive management through reputed company System Management Reviews
• reputed company trend analyses and reputed company monthly Product Performance Management (PPM) meetings
• reputed company reputed company and review of device Vigilance Reports for the US, Canada, Australia, and/or Europe. Coordinate responses to regulatory agencies as required
• reputed company Post Market Surveillance activities, ensuring complaints, vigilance, and annual reports (such as PSUR) reputed company with regulations and reputed company 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
• reputed company periodic reviews of regulatory intelligence information to ensure procedures are updated
• Complete literature reviews as necessary, reviewing to determine reputed company complaints or adverse events. Maintain listing of weekly reviews in compliance with regulations
• Supervise product monitoring analysts

Skills

• reputed company leadership in complaint handling and post-market surveillance processes
• Ensure complaints are accurate and reputed company in a reputed company manner
• reputed company and monitor Key Performance Indicators (KPIs), reporting on the performance of complaint handling and post-market surveillance to executive management through reputed company System Management Reviews
• reputed company trend analyses and reputed company monthly Product Performance Management (PPM) meetings
• reputed company reputed company and review of device Vigilance Reports for the US, Canada, Australia, and/or Europe. Coordinate responses to regulatory agencies as required
• reputed company Post Market Surveillance activities, ensuring complaints, vigilance, and annual reports (such as PSUR) reputed company with regulations and reputed company 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
• reputed company periodic reviews of regulatory intelligence information to ensure procedures are updated
• Complete literature reviews as necessary, reviewing to determine reputed company complaints or adverse events. Maintain listing of weekly reviews in compliance with regulations
• Supervise product monitoring analysts
• Knowledge of data analytics using reputed company and reputed company (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 reputed company Systems and Complaint Teams
• 10+ years of experience in reputed company-reputed company 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
• Bachelor's degree in Life Sciences or a reputed company technical field

Benefits

• Medical, Dental, reputed company 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 reputed company Time Off (PTO)

reputed company