Global Team Leader - IVDR

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ppWe are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. /ppAt SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety Environment, Quality Professionalism, Respect, Sustainability, and Leadership. /ph3Job Description /h3pThe position reports to thebHead of Delivery Operations /b /ppbMain Purpose of Role /b /pulliIn 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. /liliProvide 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). /liliLead the team of IVDR product assessors and IVDR IHC. /liliSupport the Training and Competency Manage and CV reviewer in conformity assessment and CV review. /liliDevelop, 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. /liliManage 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. /liliProvide technical advice to support all stages of the in vitro diagnostic medical device conformity assessment process in collaboration with IVDR FR CDM Team Leader. /liliDevelop, 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. /liliEstablish competence criteria for Technical Experts.



/liliApproval of mirror reviews for IVDR Product Assessors related to IVDR qualification and requalification requirements. /liliManage 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). /liliContribute 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. /li /ulpbKey Accountabilities /b /pulliMaintain a full knowledge and understanding of SGS (Global System and SGS NB 1639) procedures, Best Practices Guides, MDCG Guidance Documents and external approval criteria to allow efficient and effective technical reviews. /liliLiaise with the Medical Devices Segment Management Team to be aware and understand (emerging) developments in European regulations, procedures, methodologies and tools with respect to in vitro diagnostic medical devices. /liliProvide technical support and staff training to all parts of the SGS NB 1639 conformity assessment process to enhance the service capability of the business and clients in the in vitro diagnostic medical devices area /liliSupport business development activities as required (e.g., including follow up and/or referral of enquiries, sales visits, assistance at events, seminars) to enable on-going growth of the in vitro diagnostic medical device business. /liliSupport in the recruitment, assessment and approval process of in‑vitro diagnostic medical device auditors and product assessors to ensure adequate resource is available to meet operational and business targets /liliDevelop external training packages for clients by providing regulatory advice and guidance within the scope of notified body. /liliSupport the achievement of in vitro diagnostic medical devices operational and financial targets. /liliUndertake personal professional development and ensure appropriate training records and personal logs are updated to maintain relevant knowledge.



/liliEnsure full compliance with the Company’s Code of Integrity and Secrecy and Non-Disclosure Agreement. /liliAt all times adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company’s policies and procedures. /li /ulh3Qualifications /h3pbSkills Knowledge /b /pulliExtensive working knowledge of (in vitro diagnostic) medical device management systems, in vitro diagnostic medical device compliance and auditing and technical documentation assessment techniques. /liliEffective interpersonal skills, able to develop good working relationships with medical device teams and delivering office colleagues. /liliAppropriate knowledge and understanding of devices legislation as well as harmonised standards, CS and guidance documents. /liliAppropriate knowledge and understanding of the conformity assessment procedures provided for in the regulations for medical devices. /liliKnowledge and experience with the NB’s quality management system, related procedures and the required qualification criteria. /liliThe ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out. /liliExperience of management of cross functional global teams is an asset. /li /ulpbExperience /b /pulliFour years professional experience in the TIC industry, in the field of healthcare products or related activities, such as in design, manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed. /liliManagement experience of global teams /liliStrong and proven project management skills /liliBroad range of competency codes. /liliUnderstanding of the clinical application of the technology. /li /ulpbQualifications /b /pulliSuccessful completion of a university or technical college degree or equivalent qualification in relevant studies e.g. Microbiology, medicine, pharmacy, engineering or other relevant sciences. /li /ulpThe role can be fully remote and we are open to consider candidates located accros Europe (with valid work permit). /ppbPlease kindly write your CV in English /b /ph3Additional Information /h3ulliGlobal world leader in the TIC (Testing, Inspection and Certification) industry. /liliFlexible schedule and remotemodel. /liliSGS university and Campus for continuos learning options. /liliMultinational environment where you will work with colleagues from multiple continents. /li /ul /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hqcl8