Global Team Leader – IVDR

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

📋 Description

• This role reports directly to the Head of Delivery & Operations.

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

• Offer technical leadership and expertise to the global Medical Devices network, including sales and commercial teams, regarding in vitro diagnostic medical device certification, as well as the corresponding 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 conformity assessment and CV review activities.

• Design, update, and sustain appropriate training packages for IVDR Product Assessors within the in vitro diagnostic medical device conformity assessment process, in collaboration with the Training and Competences Manager.

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

• Provide 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 concerning the in vitro diagnostic medical devices conformity assessment process of SGS NB 1639, in partnership with the QA & RA Manager, aligned with best practices (e.g., MDCG guidance documents) and relevant regulatory and accreditation standards.

• Establish competence criteria for Technical Experts and approve mirror reviews for IVDR Product Assessors related to IVDR qualification and requalification standards.

• Oversee the development and implementation, including the approval process for IVDR Product Assessors and IVDR IHC (new personnel and ongoing monitoring and re-approval of staff).

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

⛳️ Requirements

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

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

• Solid knowledge and understanding of device legislation, harmonised standards, CS, and guidance documents.

• Comprehensive understanding of the conformity assessment procedures outlined in the regulations for medical devices.

• Familiarity and experience with the NB’s quality management system, associated procedures, and required qualification criteria.

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

• Experience in managing cross-functional global teams is a plus.

🏝️ Benefits

• Flexible scheduling and remote work model.

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

• Multinational work environment collaborating with colleagues from various continents.

• Benefits platform.