**Overview**
SGS, the world's premier testing, inspection and certification leader, seeks an experienced Senior Product Assessor to join our Medical Device team. With 99,600 employees across 2,600 global offices and laboratories, we set the standard for sustainability, quality and integrity worldwide. This remote opportunity offers career advancement for professionals with EU notified body experience in MDD/MDR technical documentation review.
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Responsibilities **
Lead and mentor a global team of Product Assessors while conducting comprehensive technical documentation reviews for Active Medical Devices. You'll ensure strict compliance with EU regulations and standards, collaborate across departments to enhance efficiency and quality, and monitor team performance including technical competencies and KPIs. Additional duties include recruiting new talent through CV reviews and interviews, developing and delivering training programs both internally and externally, addressing technical and sales inquiries for Active Medical Devices, and maintaining exceptional service standards across SGS's medical device certification network.
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Requirements **
Candidates must have proven experience as a Product Assessor, Specialist, or Technical File Reviewer with another Notified Body for active devices, conducting MDD and/or MDR reviews. We require four years of professional healthcare product experience (design, manufacturing, auditing, or research), with two years specifically in device design, manufacture, testing, or usage. Essential qualifications include Active Medical Device expertise in monitoring equipment, therapeutic devices, radiation-utilizing devices, and stand-alone software.
Strong knowledge of standards including EN 60601, EN 62304, and EN 62366 is mandatory, along with excellent written English skills for report preparation.
Monday to Friday, 9 AM – 5 PM (full-time)
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