Global Team Leader – IVDR

This is a fully remote position, open to applicants in Italy.

📋 Description

• Collaborate with the Global Head of Certification, Compliance, and the QA & RA Manager to engage with regulatory authorities and certification bodies on all technical and regulatory inquiries, ensuring the integrity and adherence to compliance of all in vitro diagnostics certification processes and decisions.

• Serve as the technical lead and provide expertise to the global Medical Devices network, including sales and commercial teams, regarding in vitro diagnostic medical device certification and the respective medical device scheme managers (ISO13485, MDSAP, UKCA).

• Oversee the team of IVDR product assessors and IVDR IHC.

• Assist the Training and Competency Manager and CV reviewer in the conformity assessment and CV review processes.

• Create, update, and maintain suitable training materials for IVDR Product Assessors involved in the in vitro diagnostic medical device conformity assessment process, in partnership with the Training and Competences Manager.

• Administer the training process for in vitro diagnostic medical device assessors, both existing and new IVDR Product Assessors and IVDR IHC, within the conformity assessment framework.

• Offer technical guidance to support all phases of the in vitro diagnostic medical device conformity assessment process, in collaboration with the IVDR FR & CDM Team Leader.

• Develop, maintain, and implement QMS documentation related to the in vitro diagnostic medical devices conformity assessment process of SGS NB 1639, working with the QA & RA Manager to align with best practices (e.g., MDCG guidance documents) and applicable regulatory and accreditation standards.

• Establish competence criteria for Technical Experts.

• Approve mirror reviews for IVDR Product Assessors concerning IVDR qualification and requalification requirements.

• Oversee the development and implementation processes for IVDR Product Assessors and IVDR IHC, including approval processes for new personnel and ongoing monitoring and re-approval of existing personnel.

• Contribute to the daily management and business development of in vitro diagnostic medical device activities to meet defined operational and financial goals while ensuring both technical and regulatory compliance.

⛳️ Requirements

• Extensive knowledge of (in vitro diagnostic) medical device management systems, compliance with in vitro diagnostic medical devices, auditing, and technical documentation assessment methods.

• Strong interpersonal skills, capable of fostering positive working relationships with medical device teams and office colleagues.

• Comprehensive understanding of device legislation, harmonized standards, CS, and guidance documents.

• Solid knowledge of the conformity assessment procedures outlined in the regulations for medical devices.

• Familiarity with the NB’s quality management system, related procedures, and necessary qualification criteria.

• Ability to prepare records and reports that demonstrate the proper execution of relevant conformity assessment activities.

• Experience in managing cross-functional global teams is advantageous.

🏝️ Benefits

• Flexible schedule and remote work model.

• Access to SGS University and Campus for continuous learning opportunities.

• Work in a multinational environment alongside colleagues from diverse continents.