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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 & life science park malta (medical products, emea and emerging markets). global submission management.

    Site Lead Publishing Team in Braine Alliance Park & Life Science Park Malta (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

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