Full-Time Product Assessor/Senior Product Assessor - Active Devices

• Join our dynamic team as a Senior Product Assessor focusing on Active Devices.
• Manage a small team of globally based Product Assessors.
• Conduct thorough technical documentation reviews and ensure compliance with EU regulations and standards.
• Collaborate with cross-functional teams to increase efficiency and quality.
• Monitor the team's technical competence, KPIs, and wellbeing.
• Conduct recruitment, including reviewing CVs and undertaking interviews.
• Develop and present training to others in SGS or externally.
• Assist with technical queries and those related to sales within the Active Medical Devices field.
• Ensure the highest level of service is provided.

• Prior experience as a Product Assessor/Specialist/Technical File Reviewer within another Notified Body for active devices.
• Experience conducting reviews against MDD and/or MDR.
• Four years of professional experience in healthcare products or related activities.
• Two years in the design, manufacture, testing, or use of active medical devices.
• Active Medical Devices knowledge (monitoring equipment, therapeutic devices, devices utilizing radiation, stand-alone software devices, etc.).
• Thorough knowledge and understanding of related standards: EN 60601, EN 62304, EN 62366, etc.
• Good written English skills.
• Knowledge of Technical File codes desirable (MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, and MDA0318).

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