Global Team Leader – IVDR

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SGS

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1878

📋 Compliance

☁️ SaaS

Compliance • SaaS • Sustainability

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, liase with regulatory authorities and other certification bodies on all technical/regulatory questions to ensure the integrity and compliance of all in vitro diagnostics certification processes and decisions. • Provide technical lead and expertise to the global Medical Devices network, including the sales and commercial teams, relating to in vitro diagnostic medical device certification, as well as the respective medical device scheme managers (ISO13485, MDSAP, UKCA). • Lead the team of IVDR product assessors and IVDR IHC. • Support the Training and Competency Manage and CV reviewer in conformity assessment and CV review. • Develop, update and maintain appropriate training packages for IVDR Product Assessors within the in vitro diagnostic medical device conformity assessment process in collaboration with Training and competences manager. • Manage the in vitro diagnostic medical device training process for both existing and new IVDR Product Assessors and IVDR IHC within the in vitro diagnostic medical device conformity assessment process. • Provide technical advice to support all stages of the in vitro diagnostic medical device conformity assessment process in collaboration with IVDR FR & CDM Team Leader. • Develop, maintain and implement QMS documentation related to in vitro diagnostic medical devices conformity assessment process of SGS NB 1639 with QA & RA Manager, aligned with best practices (e.g. MDCG guidance documents) and applicable regulatory and accreditation requirements. • Establish competence criteria for Technical Experts. • Approval of mirror reviews for IVDR Product Assessors related to IVDR qualification and requalification requirements. • Manage the development and implementation, including approval process for and IVDR Product Assessors and IVDR IHC (new personnel & for on-going monitoring and re-approval of personnel). • Contribute to the day-to-day management and business development of the in vitro diagnostic medical devices activities to achieve defined operational and financial targets and maintain both technical and regulatory compliance.

🎯 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