Post Market Surveillance Coordinator

Job Summary

To support ongoing regulatory compliance, the remote Post Market Surveillance Coordinator will manage product performance monitoring, analyze post-market feedback, and drive process improvements in a full-time capacity.

Key responsibilities

• Oversee post-market surveillance processes related to product performance monitoring and reporting
• Manage the design and implementation of post-market surveillance activities and processes
• Collaborate with cross-functional teams to analyze product safety and performance data, ensuring compliance with regulations

Required qualifications

• 6+ years of experience in quality systems and regulatory reporting, or 4+ years with a Master's degree
• Experience in post-market signaling and real-world evidence tracking
• Expertise in continual improvement and risk management within a quality management system
• Familiarity with regulatory submissions (e.g., 510k, EU Technical Documentation)
• Experience in the medical device industry or equivalent, particularly with SaMD