Senior Product Assessor - Active Devices

Job Summary

A company is looking for a Product Assessor / Senior Product Assessor - Active Devices.

Key Responsibilities

• Support and guide a team of Product Assessors in technical documentation reviews
• Ensure compliance with EU regulations and standards while collaborating with cross-functional teams
• Monitor team performance and provide feedback, including conducting recruitment and training

Required Qualifications

• Four years of professional experience in healthcare products or related activities, with two years in design or manufacturing of active devices
• Knowledge of Active Medical Devices, including monitoring equipment and therapeutic devices
• Thorough understanding of related standards such as EN 60601, EN 62304, and EN 62366
• Familiarity with Technical File codes as per EU regulations
• Good written English skills for report review and queries