Global Team Leader – IVDR

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

📋 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 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, as well as the relevant 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 as part of the in vitro diagnostic medical device conformity assessment process in partnership with the Training and Competencies Manager.

• Manage 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 coordination with the IVDR FR & CDM Team Leader.

• Develop, sustain, and execute QMS documentation concerning the in vitro diagnostic medical devices conformity assessment process of SGS NB 1639, in alignment with best practices (e.g., MDCG guidance documents) and relevant regulatory and accreditation standards.

• Define competence criteria for Technical Experts.

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

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

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

⛳️ Requirements

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

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

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

• Adequate knowledge and understanding of the conformity assessment procedures outlined in the regulations for medical devices.

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

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

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

🏝️ Benefits

• Flexible schedule and remote work options.

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

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

• Comprehensive benefits platform.