Job Description

The position reports to the Head of Delivery & Operations

Main Purpose of Role

• 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 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 Manager and CV reviewer in conformity assessment and CV review.
• Develop, update and maintain appropriate training packages for IVDR Product Assessors within the in ...