Senior Product Assessor, Active Devices

A company is looking for a 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 Education

Four years of 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 relevant standards (e.g., EN 60601, EN 62304, EN 62366)

Good written English skills for report preparation

Mandatory knowledge of Technical File codes MDA 0304 & MDA 0314

Familiarity with additional Technical File codes is a plus