Certification Project Manager - In Vitro Diagnostics

Responsibilities

• Manage a portfolio of In Vitro Diagnostic (IVD) manufacturers to pilot conformity assessment processes for certification projects
• Initiate and monitor CE marking and Quality Management System (QMS) certification files
• Define and plan all certification process stages in coordination with planning teams
• Consolidate conclusions from evaluations (audits, technical documentation) and present them to the decision committee
• Act as the primary point of contact for clients, ensuring clear and structured communication
• Maintain regulatory and normative watch regarding IVD (IVDR, technical standards, scientific evolutions)
• Support commercial teams with needs qualification and offer preparation

Requirements

• Master's degree (Bac+5) in biology, biochemistry, biotechnology, or an equivalent field
• Minimum 2 years of experience in the healthcare sector, ideally with a manufacturer or in a laboratory environment related to IVD
• Practical experience with IVD devices and their implementation
• Experience working within a structured quality system (e.g., ISO 13485)
• Proficiency in documentation, traceability, gap management, and CAPA
• Professional fluency in both French and English (written and oral)
• Strong organizational skills and ability to manage multiple projects simultaneously

About the Company

GMED is a French notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 for the conformity assessment of medical devices. We are an international reference for the certification of Quality Management Systems for medical device manufacturers.