Global Team Leader – IVDR

About the role

SGS is seeking a Global Team Leader for In‑Vitro Diagnostic Regulation (IVDR) to steer the certification and compliance activities of its medical‑device portfolio worldwide. Reporting to the Head of Delivery & Operations, you will act as the primary liaison with regulatory authorities and certification bodies, ensuring the integrity of all IVDR processes.

Key responsibilities

• Coordinate with the Global Head of Certification, QA & RA Manager, and regulatory agencies on technical and regulatory matters.
• Provide technical leadership to the global medical‑devices network, including sales, commercial teams, and scheme managers (ISO 13485, MDSAP, UKCA).
• Lead and develop the IVDR product assessors and IVDR IHC teams, overseeing training, competency, and CV reviews.
• Design, update, and maintain training packages for IVDR assessors in collaboration with the Training & Competences Manager.
• Develop and implement QMS documentation for IVDR conformity assessment (SGS NB 1639) aligned with MDCG guidance and regulatory requirements.
• Establish competence criteria for technical experts and approve mirror reviews for IVDR assessors.
• Contribute to day‑to‑day management and business development of IVDR activities to meet operational and financial targets.

Required profile

• Extensive experience in in‑vitro diagnostic regulation and medical‑device certification.
• Proven leadership skills managing multidisciplinary, global teams.
• Strong knowledge of regulatory frameworks such as IVDR, ISO 13485, MDSAP, and UKCA.
• Excellent communication skills for interaction with authorities, internal stakeholders, and external partners.

Required skills

• IVDR regulatory expertise
• ISO 13485
• MDSAP
• UKCA
• Quality Management System (QMS) documentation
• MDCG guidance interpretation

What we offer

• Dynamic, international work environment within a global leader in testing, inspection, and certification.
• Opportunities for professional development and long‑term career growth.
• Commitment to sustainability, integrity, and high professional standards.