Global Team Leader - IVDR

About the role

SGS, a global testing, inspection and certification company, is looking for a Global Team Leader for its in vitro diagnostics (IVDR) medical device conformity assessment business. The role reports to the Head of Delivery & Operations and works closely with the Global Head of Certification and Compliance and the QA & RA Manager. It provides technical leadership to the global medical devices network and leads the team of IVDR product assessors and IVDR IHC.

Key responsibilities

• Liaise with regulatory authorities and certification bodies on technical and regulatory questions to ensure compliance of IVDR certification processes.
• Provide technical expertise to the global medical devices network, including sales and commercial teams and scheme managers (ISO 13485, MDSAP, UKCA).
• Lead the team of IVDR product assessors and IVDR IHC, and support the training and competency management and CV review.
• Develop and maintain training packages and manage training for existing and new assessors and IHC.
• Manage the development and approval of IVDR product assessors and IHC, including mirror reviews and ongoing monitoring and re-approval.
• Develop and maintain QMS documentation for SGS NB 1639, aligned with MDCG guidance and regulatory requirements, and establish competence criteria for Technical Experts.
• Support business development, recruitment of auditors and product assessors, and contribute to operational and financial targets while maintaining technical and regulatory compliance.

Required profile

• University or technical college degree in a relevant field such as microbiology, medicine, pharmacy, engineering or another science.
• Four years of professional experience in the TIC industry, healthcare products or related activities, with two years in design, manufacture, testing or use of the device or its scientific aspects.
• Management experience of global teams and strong, proven project management skills.
• Experience managing cross-functional global teams is an asset.

Required skills

• Working knowledge of medical device management systems, compliance and auditing, and technical documentation assessment.
• Knowledge of medical device legislation, harmonised standards, CS and guidance documents, and conformity assessment procedures.
• Knowledge of the notified body's quality management system and qualification criteria.
• Ability to draw up records and reports showing conformity assessment activities were properly carried out.

What we offer

• The role can be fully remote and candidates across Europe with a valid work permit are considered.
• Flexible schedule and remote model.
• SGS university and campus for continuous learning options.
• Benefits platform and a multinational environment.