13 set - Cuneo
Sgs
We 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.
At 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.
Job Description The position reports to theHead of Delivery & Operations
Main Purpose of Role
- 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 me
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