Global Team Leader – IVDR

SGS

Global Team Leader at SGS managing in vitro diagnostics certification processes with a focus on regulatory compliance and team leadership. Providing expertise and guidance to the medical devices network and supporting business development.

Posted 7/29/2026full-timeRemote • 🇵🇹 PortugalSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive knowledge of In Vitro Diagnostic Medical Device management systems, compliance, and auditing, along with the ability to lead cross-functional global teams and liaise with regulatory authorities effectively.

Highest-signal resume keywords

In Vitro Diagnostic Medical Device Management SystemsMedical Device ComplianceTechnical Documentation AssessmentConformity Assessment ProceduresCross-Functional Team Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Technical Documentation Assessment TechniquesMedical Device Legislation KnowledgeQuality Management System KnowledgeConformity Assessment Activities ReportingIVDR Product Assessment Management

Soft Skills

Effective Interpersonal SkillsRelationship Development

Industry Keywords

In Vitro Diagnostic Medical DevicesRegulatory Authorities LiaisonHarmonised StandardsCertification BodiesAuditing Techniques

About the role

Key responsibilities & impact

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
Provide technical lead and expertise to the global Medical Devices network, including the sales and commercial teams
Lead the team of IVDR product assessors and IVDR IHC
Manage the development and implementation, including approval process for IVDR Product Assessors and IVDR IHC (new personnel & for on-going monitoring and re-approval of personnel)
Support business development activities as required to enable ongoing growth of the in vitro diagnostic medical device business
Undertake personal professional development and ensure appropriate training records and personal logs are updated to maintain relevant knowledge.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Flexible schedule and remote model
SGS university and Campus for continuos learning options
Multinational environment where you will work with colleagues from multiple continents