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
• Conduct technical documentation reviews for compliance with EU regulations
• Collaborate with cross-functional teams to enhance efficiency and quality

Required Qualifications and Experience

• Four years of professional experience in healthcare products or related fields, with two years in design, manufacture, testing, or use of active devices
• Knowledge of Active Medical Devices and related standards (e.g., EN 60601, EN 62304, EN 62366)
• Experience in conducting reviews against MDD and/or MDR within a Notified Body
• Familiarity with Technical File codes as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185
• Good written English skills for report reviews