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Summary

Specialties: Regulatory Affairs, Compliance, European Regulations, eCTD and electronic submissions, Medical Devices, Quality Managements Systems, Medical Information, Pharmacovigilance.

Experiences

Current Experience

  • Manager, Regulatory Operations and Compliance - Global Submission Management
    Since December 2013
    Site Lead Publishing Team in Braine Alliance Park (Medical Products, EMEA and Emerging Markets). Global Submission Management.

Past Experience

  • Regulatory Affairs Manager
    January 2012 --- December 2013
    Responsible for Regulatory Affairs, Quality Management System and Pharmacovigilance in the Belgian Affiliate.

  • Senior Associate Regulatory Affairs & Compliance
    August 2009 --- September 2011
    Mainly involved in Clinical Studies, Registration and Healthcare Compliance.

  • Regulatory Affairs Operations Associate
    October 2006 --- August 2009
    Creation of electronic and paper RA submissions in EU (National, MRP, PSUR, ...).

  • Safety Operations Specialist
    April 2005 --- October 2005
    Post-marketing surveillance for Medical Devices in EU.

  • Medication Delivery
    October 2000 --- April 2005

Knowledge

LinkedIn Assessment :
Regulatory affairseCTDPharmaceutical IndustryManagement Of Direct ReportsProject ManagementDocument ManagementMedical DevicesPharmacovigilanceRegulatory submissionsGMPRegulatory RequirementsBiopharmaceuticalsComplianceBiotechnologyMedical InformationPharmaceuticalsClinical trialsSOPQuality SystemsCAPAHealthcare Marketing ComplianceGood Distribution Practice (GDP)DermatologyThrombosisoncologyRenal Nutrition

Education

  • in bio-engineering from Vrije Universiteit Brussel in 2000
  • in Maths (8h) - Science from Koninklijk Atheneum Koekelberg in 1994

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
French
Full Proficiency
English
Full Proficiency
German
Elementary Proficiency

Work Preferences

  • Notice Period:
    6 weeks
  • Locations I am interested in:
    Brussels, Belgium
  • Work From Home:
    Yes, 1 to 0 days per week
  • Work Regime:
    Permanent position
  • International:
    No

Area / Region

Etterbeek, Belgium

Others

Driving License
  • Yes