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Senior Product Assessor, Active Devices

Senior Product Assessor, Active Devices

VirtualVocationsSouth Bend, Indiana, United States
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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

Four years of professional experience in healthcare products or related activities

Two years of experience in design, manufacture, testing, or use of active medical devices

Knowledge of related standards such as EN 60601, EN 62304, EN 62366

Familiarity with Technical File code MDA 0314 is mandatory

Good written English skills for report preparation

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Assessor • South Bend, Indiana, United States

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