Worldwide coordination of compliance plan for subsidiaries, in Quality Post Market team.Manage the continuous improvement plan in line with the Global quality roadmap.Proactively prepare for ANSM and FDA inspections.

EMEA Quality Manager of 7 Clusters (France , Iberia, Adriatic, NEC, CEC, METER, Africa). Quality team of 35 collaborators. Definition and implementation of improvement plan for all EMEA Subsidiaries. Simplification and Harmonisation of the QMS, ISO 9001/13485/MDSAP certifications, support for Brexit preparation plan.Coordination of EMEA projects, such as Distributors management, Vigilance and complaint processes improvement, Training, Management review, MAID compliance for EU IVD Regulation… Show more EMEA Quality Manager of 7 Clusters (France , Iberia, Adriatic, NEC, CEC, METER, Africa). Quality team of 35 collaborators. Definition and implementation of improvement plan for all EMEA Subsidiaries. Simplification and Harmonisation of the QMS, ISO 9001/13485/MDSAP certifications, support for Brexit preparation plan.Coordination of EMEA projects, such as Distributors management, Vigilance and complaint processes improvement, Training, Management review, MAID compliance for EU IVD Regulation. Team development. Show less

Preparation of Inspections (FDA, CFDA, ANSM, WHO, ...), Project leader for MDSAP certification, new versions of ISO 13485 and 9001. Implementation of Compliance action plan and Risk Based Approach for EMEA Manufacturing sites.

Project Leader for the preparation phase of the new IVD Regulation in Europe (gap analysis with the new IVDR, program implementation with ExCom governance, Training and Communication on the new IVDR. Impact analysis and action plan on : Reclassification, Technical documentation,Vigilance and PMS, Clinical Evidence Report, Risk Management File, New obligations of economics operators, ....).Lean 6sigma project for electronic International Registration File implementation and enhance global… Show more Project Leader for the preparation phase of the new IVD Regulation in Europe (gap analysis with the new IVDR, program implementation with ExCom governance, Training and Communication on the new IVDR. Impact analysis and action plan on : Reclassification, Technical documentation,Vigilance and PMS, Clinical Evidence Report, Risk Management File, New obligations of economics operators, ....).Lean 6sigma project for electronic International Registration File implementation and enhance global Regulatory Affairs Processes. Show less