SGS
10,000+ employees
Founded 1878
💼 Consulting
🏥 Healthcare
🍽️ Food & Beverage
Consulting • Healthcare • Food & Beverage
SGS is the world's leading Testing, Inspection, and Certification (TIC) company, providing a comprehensive range of services designed to assure quality and integrity across various sectors. SGS is focused on sustainability, offering climate action services and an all-encompassing ESG portfolio under its IMPACT NOW suite. The company has ambitious targets for growth by 2027, driven by its strategy to address global megatrends. SGS operates globally, providing business assurance, connectivity and products, digital trust, health and nutrition, and solutions for industries and the environment.
Global Team Leader – IVDR
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🔥 0 minutes ago
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SGS
10,000+ employees
Founded 1878
💼 Consulting
🏥 Healthcare
🍽️ Food & Beverage
Consulting • Healthcare • Food & Beverage
SGS is the world's leading Testing, Inspection, and Certification (TIC) company, providing a comprehensive range of services designed to assure quality and integrity across various sectors. SGS is focused on sustainability, offering climate action services and an all-encompassing ESG portfolio under its IMPACT NOW suite. The company has ambitious targets for growth by 2027, driven by its strategy to address global megatrends. SGS operates globally, providing business assurance, connectivity and products, digital trust, health and nutrition, and solutions for industries and the environment.
📋 Description
• In conjunction with Global Head of Certification and compliance and QA & RA Manager, liaise with regulatory authorities and other certification bodies on all technical/regulatory questions • Provide technical lead and expertise to the global Medical Devices network, including the sales and commercial teams • Lead the team of IVDR product assessors and IVDR IHC • Manage the development and implementation, including approval process for IVDR Product Assessors and IVDR IHC (new personnel & for on-going monitoring and re-approval of personnel) • Support business development activities as required to enable ongoing growth of the in vitro diagnostic medical device business • Undertake personal professional development and ensure appropriate training records and personal logs are updated to maintain relevant knowledge.
🎯 Requirements
• Extensive working knowledge of (in vitro diagnostic) medical device management systems, in vitro diagnostic medical device compliance and auditing and technical documentation assessment techniques. • Effective interpersonal skills, able to develop good working relationships with medical device teams and delivering office colleagues. • Appropriate knowledge and understanding of devices legislation as well as harmonised standards, CS and guidance documents. • Appropriate knowledge and understanding of the conformity assessment procedures provided for in the regulations for medical devices. • Knowledge and experience with the NB’s quality management system, related procedures and the required qualification criteria. • The ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out. • Experience of management of cross functional global teams is an asset.
🏖️ Benefits
• Flexible schedule and remote model • SGS university and Campus for continuos learning options • Multinational environment where you will work with colleagues from multiple continents
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