**Overview**
Join SGS, the world's premier testing, inspection and certification organization, as a Product Assessor specializing in Cardiovascular and Soft Tissue medical devices. Based remotely, you'll play a crucial role in our global network of 2,600 offices and laboratories, contributing to safer healthcare solutions worldwide. This position focuses on thorough evaluation of medical devices while ensuring regulatory compliance across European and UK markets.
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Responsibilities **
• Perform detailed assessments of Cardiovascular and Soft Tissue medical products, reviewing technical documentation for Class IIa/IIb and Class III devices • Ensure all evaluations meet European Medical Device Regulation (MDR), Medical Device Directive (MDD), and UKCA standards • Provide technical support for CE marking processes conducted by SGS • Mentor junior team members and develop comprehensive training resources • Maintain clear communication with colleagues and clients throughout assessment processes • Work to reduce certification risks and support ongoing medical device compliance
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Requirements **
• Extensive background in healthcare product design, manufacturing, regulation, auditing, or research • Specialized expertise with Cardiovascular and Soft Tissue device development, testing, or application • University degree in medicine, pharmacy, engineering, or related scientific field • Strong written and verbal English communication abilities • Comprehensive understanding of non-active medical device categories per Commission Regulation 2017/2185, including soft-tissue implants (MDN 1104), emergency care devices (MDN 1201), substance administration systems (MDN 1202), wound care products (MDN 1204), ophthalmologic devices (MDN 1206), and contraceptive products (MDN 1210) • Previous experience as Technical File reviewer for Certification/Notified body preferred
Monday to Friday, 9 AM – 5 PM (full-time)
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