Product Monitoring Manager

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Therakos Institute

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Pharmaceuticals

Therakos Institute is the professional education and resources arm of Therakos (Therakos LLC) focused on supporting healthcare professionals who use the THERAKOS CELLEX photopheresis system and UVADEX (methoxsalen) sterile solution. The site and Institute provide clinical information, operator training, patient identification guidance, prescribing resources for extracorporeal photopheresis (ECP), customer support, and access/navigation help for treatment of cutaneous T-cell lymphoma (CTCL) and related photopheresis procedures. Content is intended for US healthcare professionals and emphasizes safety, prescribing information, and operator competence for use of the THERAKOS device and associated drug.

📋 Description

• Oversee product complaints and post-market surveillance in accordance with ISO 13485:2016, MDSAP, EU MDR, and other pertinent regulations. • Supervise a team and ensure sufficient resources are available to fulfill complaint handling and post-market surveillance-related responsibilities.

🎯 Requirements

• 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.

🏖️ 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)