[Hiring] Global Team leader - IVDR @SGS

Role Description

The position reports to the Head of Delivery & Operations.

Main Purpose of Role:

• In conjunction with Global Head of Certification and compliance and QA & RA Manager, liaise with regulatory authorities and other certification bodies on all technical/regulatory questions to ensure the integrity and compliance of all in vitro diagnostics certification processes and decisions.
• Provide technical lead and expertise to the global Medical Devices network, including the sales and commercial teams, relating to in vitro diagnostic medical device certification, as well as the respective medical device scheme managers (ISO13485, MDSAP, UKCA).
• Lead the team of IVDR product assessors and IVDR IHC.
• Support the Training and Competency Manager and CV reviewer in conformity assessment and CV review.
• Develop, update and maintain appropriate training packages for IVDR Product Assessors within the in vitro diagnostic medical device conformity assessment process in collaboration with Training and Competences Manager.
• Manage the in vitro diagnostic medical device training process for both existing and new IVDR Product Assessors and IVDR IHC within the in vitro diagnostic medical device conformity assessment process.
• Provide technical advice to support all stages of the in vitro diagnostic medical device conformity assessment process in collaboration with IVDR FR & CDM Team Leader.
• Develop, maintain and implement QMS documentation related to in vitro diagnostic medical devices conformity assessment process of SGS NB 1639 with QA & RA Manager, aligned with best practices (e.g. MDCG guidance documents) and applicable regulatory and accreditation requirements.
• Establish competence criteria for Technical Experts.
• Approval of mirror reviews for IVDR Product Assessors related to IVDR qualification and requalification requirements.
• Manage the development and implementation, including approval process for IVDR Product Assessors and IVDR IHC (new personnel & for ongoing monitoring and re-approval of personnel).
• Contribute to the day-to-day management and business development of the in vitro diagnostic medical devices activities to achieve defined operational and financial targets and maintain both technical and regulatory compliance.

Qualifications

• Extensive working knowledge of (in vitro diagnostic) medical device management systems, in vitro diagnostic medical device compliance and auditing and technical documentation assessment techniques.
• Effective interpersonal skills, able to develop good working relationships with medical device teams and delivering office colleagues.
• Appropriate knowledge and understanding of devices legislation as well as harmonised standards, CS and guidance documents.
• Appropriate knowledge and understanding of the conformity assessment procedures provided for in the regulations for medical devices.
• Knowledge and experience with the NB’s quality management system, related procedures and the required qualification criteria.
• The ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
• Experience of management of cross-functional global teams is an asset.

Requirements

• Four years professional experience in the TIC industry, in the field of healthcare products or related activities, such as in design, manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.
• Management experience of global teams.
• Strong and proven project management skills.
• Good stakeholder management skills.

Benefits

• Global world leader in the TIC (Testing, Inspection and Certification) industry.
• Flexible schedule and remote model.
• SGS university and Campus for continuous learning options.
• Multinational environment where you will work with colleagues from multiple continents.
• Benefits platform.