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St. Jude Medical
- Senior Manager Clinical Safety International Division
Boulogne-Billancourt
2012 - maintenant
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Kimberly-Clark
- Head RA & QA EMEA
Nanterre
2010 - 2011
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Vexim
- Head Clinical & Regulatory Affairs
BALMA
2008 - 2009
- Organisation and coordination of the regulatory, clinical, medical and reimbursement department
- Clinical Affairs: Clinical strategy according to the development of our devices, Budget, Coordination, Follow-up, Contact with competent authorities
- Regulatory Affairs: CE-mark dossier (EU), 510(k) dossier (USA), Local and national registration (strategy & coordination according to the development and sales objectives), Local and national legislations related to the medical devices, Compliance, Vigilance, Complaints handling, Audits, Product release, Contracts with distributors, Quality (Procedures)
- Medical Affairs: Publication (strategy & coordination), Scientific committee (creation & coordination), Congresses (strategy & coordination)
- Reimbursement Affairs: Strategy and coordination
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Health Care &Medical Devices Consulting
- Consultant
2005 - maintenant
- Belgian and international legislation related to health care and medical devices: follow up and interpretation
- Regulatory affairs and compliance (CE-mark dossier (EU), 510(k) dossier (USA), Local and national registration (strategy & coordination according to the development and sales objectives), Local and national legislations related to the medical devices, Compliance, Vigilance, Complaints handling, Audits, Product release, Contracts with distributors, Quality (Procedures))
- Clinical affairs (Clinical strategy according to the development of the devices, Budget, Coordination, Follow-up, Contact with competent authorities)
- Medical affairs (Publication (strategy & coordination), Scientific committee (creation & coordination), Congresses (strategy & coordination))
- Organisation and coordination of the regulatory, clinical, medical and reimbursement department)
- Reimbursement affairs (from the strategy to the submission dossier)
- Ministry of Economy (FPS Economy): price dossiers for implants
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Kyphon
- Regulatory Compliance Manager
2005 - 2008
- Organisation and coordination of the regulatory department
- Belgian, European and International legislation related to health care and medical devices: follow up and interpretation
- Regulatory compliance: Complaints handling (organisation and co-coordination of a new process; Post-market surveillance (clinical studies); Quality and safety (reuse, CAPA, …); Environment (REACH, WHEE, RHOS); Standards management; …
- Regulatory affairs (world-wide): international registration, authorize representative function, quality, product release (shipping table) management, …
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UNAMEC (Belgian trade association)
- Advisor (regulatory and reimbursement)
2002 - 2005
- Belgian and European legislation related to health care and medical devices: follow up and interpretation
- Regulatory affairs and normalisation
- Health care nomenclature: reimbursement files for implants and medical devices
- Ministry of Economy (FPS Economy): price dossiers for implants
- Financing of the hospitals
- Relations with the authorities (ministry, parliament, administration, …) and the media
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Free University of Brussels
- Assistant & Researcher
1995 - 2002
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Clinique Notre-Dame de Grâce - Gosselies
- Nursing officer of the Intensive Care Unit (ICU)
1993 - 1995
Reorganisation and stabilization of the unit and the team after 18 months without nursing officer
Training, evaluation, management of a team (22 nurses)
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C.U.B. Hôpital Erasme
- Nurse
1983 - 1993
Nurse, successively:
- Flying team: 1 year (Pneumology, ICU, Nephrology)
- ICU: 5 years (during my pregnancies: transfer to units: Clinical Pharmacology, Neurology, Gynaecology and Urology)
- Operating room: 4 years (Department of Abdominal Surgery)
