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Product Assessor - Active Devices
Product Assessor - Active Devices-February 2024
Columbus
Feb 22, 2026
About Product Assessor - Active Devices

  Company DescriptionWe are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 98,000employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world.Excited about a career at SGS?Join us as a Product Assessor - Active Devices in our successful certification division. As global leaders, SGS thrives on 100% passion, pride, and innovation. We embrace new ideas and are committed to helping you reach your full potential.Job DescriptionAs a Product Assessor in our Medical Device team, your role is pivotal. You'll conduct technical file reviews aligned with the European Medical Device Directive and Medical Device Regulation for Class IIa/IIb and/or Class III, ensuring both technical soundness and full compliance with requirements. Additionally, you'll actively contribute to training junior staff and developing training materials.Specifically, you will:* Ensure regulatory compliance in product technical file assessments under EU Medical Devices Directives and/or Regulations.* Conduct product assessments, primarily desk-based but occasionally on-site, following established procedures and maintaining a high standard of service delivery.* Sustain personal competence and development in specialized areas for consistent evaluation of product technical documentation.* Project manage assessments to maximize efficiencies, enhance client satisfaction, and ensure compliance with requirements.* Assist in addressing queries arising from product assessments.* Adhere to set Key Performance Indicators (KPIs) both individually and within a team.* Ensure the highest level of service delivery throughout the SGS network, contributing to efficient medical devices certification for stakeholders.Qualifications* 4 + Years of professional experience in healthcare products or related fields, encompassing roles in design, manufacturing, auditing, or research. Specifically, a minimum of two years should be dedicated to the design, manufacture, testing, or utilization of the device or technology under assessment, or be related to the scientific aspects being evaluated.* Active knowledge of Medical Devices, including monitoring equipment, therapeutic devices, devices utilizing radiation, and stand-alone software devices, acquired through hands-on experience in designing, manufacturing, or testing such devices.* Thorough familiarity with relevant standards such as EN 60601, EN 62304, EN 62366, demonstrating a comprehensive understanding of industry guidelines.* Strong written English skills are essential, as reports will undergo review and may be subject to queries in English.* Desirable familiarity with Technical File codes, including MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, MDA0318Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjAwNDQ1LjEwNTA4QHNnc25vcnRoYW1lcmljYWNvbXAuYXBsaXRyYWsuY29t

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