Remote IVDR Global Team Lead – Medical Devices

SGS Italia; Pandino; Remote; EUR 90,000 - 130,000; Full time

Job summary

SGS Italia is seeking a senior expert to lead the IVDR certification activities within the global Medical Devices network. You will coordinate with regulatory authorities, support conformity assessment, and guide the IVDR product assessors and IHC teams to maintain compliance and quality.

The role can be fully remote across Europe and requires four years in TIC with healthcare products, plus strong project management and stakeholder skills.

Qualifications

• Four years professional TIC experience in healthcare products or related activities.
• Management experience of global teams.
• Strong project management skills.
• Good stakeholder management.
• Broad range of competency codes.
• Understanding of clinical application of technology.

Responsibilities

• Liase with regulatory authorities on technical/regulatory questions to ensure integrity and compliance of IVDR processes.
• Provide technical lead to the Medical Devices network on IVDR certification, including scheme managers (ISO13485, MDSAP, UKCA).
• Lead the team of IVDR Product Assessors and IVDR IHC.
• Develop, update and maintain training packages for IVDR Product Assessors.
• Manage the IVDR training process for existing and new assessors and IHC.
• Provide technical advice to support all stages of conformity assessment in collaboration with IVDR Team Leader.
• Establish competence criteria for Technical Experts.
• Approve mirror reviews for IVDR Product Assessors.
• Contribute to day-to-day management and business development of IVDR activities.

Skills

IVDR expertise

Regulatory knowledge

Auditing

Project management

Stakeholder management

Education

Degree in Microbiology / Medicine / Pharmacy / Engineering

Job description

SGS Italia is seeking a senior expert to lead the IVDR certification activities within the global Medical Devices network. You will coordinate with regulatory authorities, support conformity assessment, and guide the IVDR product assessors and IHC teams to maintain compliance and quality.

The role can be fully remote across Europe and requires four years in TIC with healthcare products, plus strong project management and stakeholder skills.