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Experiences

Current Experience

  • RA Manager Pre-Market BD Life Sciences
    Since October 2016

Past Experience

  • RA Manager Post-Market BD Biosciences & BD Diagnostic Systems
    October 2013 --- September 2016

  • European Regulatory Compliance Manager
    October 2007 --- October 2013

  • Scientific Support Coordinator
    October 2005 --- September 2007

  • Scientific Support Specialist
    July 2000 --- October 2005

Knowledge

Self Assessment :
Cell biologyAdverse Events (AE)AntibodiesBiotechnologyCancer ResearchCoachingComplianceCompliance with regulationsDiagnosticsFlow CytometryImmunologyIn vitro diagnostics (IVD)Life SciencesMedical DevicesRegistration of the productRegulatory ComplianceRegulatory affairsRisk ManagementSerious Adverse Event (SAE)Understanding of regulatory guidelines
LinkedIn Assessment :
BiotechnologyLifesciencesImmunologymolecular biologyFlow CytometryCell biologyCell CultureMicrobiologyBiochemistryGenomicsCellHardware DiagnosticsRegulatory affairsCAPAFDAAssay developmentLaboratoryLaboratory AutomationMedical DevicesBiomedical EngineeringClinical trialsValidationTechnology transferISO 13485ImmunoassaysCommercializationBiopharmaceuticalsGMPInfectious diseasesLife Sciences

Education

  • Doctor in Biotechnology in Biotechnology, Cancer Research from Ghent University in 2000
  • Ph.D. Biotechnology in Science from Universiteit Gent in 2000
  • Biotechnology in from Universiteit Gent in 1994
  • Gegradueerde in de Kinesitherapie in kinesitherapie from simon stevin in 1990
  • Master in Physiotherapist from Simon Steven in 1990
  • in from KA Brugge in 1985

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Professional Proficiency
French
Professional Proficiency

Work Preferences

  • Positions I am interested in:
    Compliance Manager Director Regulatory Affairs Regulatory Affairs Manager
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Erembodegem, Aalst, Belgium

Others

Driving License
  • Yes