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 ensuring 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
Knowledge of Active Medical Devices through design, manufacturing, or testing
Thorough understanding of related standards such as EN 60601, EN 62304, EN 62366
Mandatory knowledge of Technical File codes MDA 0304 & MDA 0314
Good written English skills for report review and queries
Assessor • Carrollton, Texas, United States