• 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.

• Liaise with regulatory authorities and other certification bodies on all technical/regulatory questions • Provide technical lead and expertise to the global Medical Devices network • Lead the team of IVDR product assessors • Manage the in vitro diagnostic medical device training process for both existing and new IVDR Product Assessors • Develop external training packages for clients by providing regulatory advice and guidance

• The position reports to the Head of Delivery & Operations • 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 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 ongoing 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.

• Build strong relationships and facilitate an unparalleled advocacy experience for patients. • Collaborate with healthcare advocates to help patients achieve health goals. • Contribute to the development of a new patient care program to optimally serve a vulnerable population.