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Summary

specialties: see competencies

Experiences

Current Experience

  • R&D Director

    Wavre, Belgium
    Since January 2017

  • Founder

    Balâtre, Jemeppe-sur-Sambre, Belgium
    Since July 2013

Past Experience

  • Senior Manager Market Access, Reimbursement and Regulatory Affairs Wavre, Belgium

    March 2015 --- December 2016

  • QA/RA/Clinical Affairs Manager Isnes, Belgium

    January 2012 --- March 2015

  • Sr Manager Global Technical Services QA Wavre, Belgium

    March 2010 --- December 2011

  • Reliability and Quality Engineer Braine-l'Alleud, Belgium

    May 2009 --- March 2010

  • Validation Manager Heppignies, Belgium

    January 2006 --- January 2009

  • Technical Manager Heppignies, Belgium

    September 2003 --- September 2006

  • Technical Assistant Heppignies, Belgium

    August 2002 --- September 2003

Personality

Self Assessment :
Creative thinkingAdaptabilityAnalytical thinkingAuthenticityCommunicativeCuriosityFlexibilityInnovative thinkingProblem solvingStrategic thinking

Knowledge

Self Assessment :
Quality Management System (QMS)Regulatory affairsClinical trialsMarket accessHealthcare ReimbursementOphthalmologyVascular surgeryVaccinesLean ManufacturingGood Manufacturing Practice (GMP)ISO 9001ISO 13485ISO 14971ISO 10993Business ProcessesCE CertificationIDE submissionsProject ManagementCleanroomValidationProduct developmentQuality Auditing93/42/EECMedical Device R&DMedical DevicesAseptic ProcessingSterilizationSterile drug products
LinkedIn Assessment :
Dispositif mISO 13485SystValidationMedical DevicesContrLean Six Sigma Green BeltPharmaceutical Facility DesignAseptic ProcessingQuality EngineeringQuality SystemsSterilizationAutoclaveMedical Device DirectiveRegulatory affairsClinical trialsPost Market SurveillanceDesign and DevelopmentSecteur pharmaceutiqueBPFAssurance qualitQuality AssuranceQuality SystemPharmaceutical IndustryGMPQuality Controlmanagement

Skills and Expertise

Self Assessment :
Interact with nurses Interact with physicians Search literature on clinical trials Analytical skills Create SOPs Develop protocols Technology researchAssemble regulatory applicationsSubmit regulatory applicationsEthics committee submissionsGenerate regulatory submissions Develop Quality Risk Management (QRM) initiativesDevelop regulatory strategyDevelop Quality Management SystemsImplement Quality Management System (QMS)Develop medical devices

Education

  • Master of Business Administration (M.B.A.) in Business Administration and Management, General from Louvain School of Management in 2016
  • Master’s Degree in Mechanical Engineering from Faculté Polytechnique de Mons in 2001

Training and Certification

  • ISO 13485:2016 in 2017 Training
  • Lean Six Sigma Green Belt in 2005 Certification

Languages

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

Work Preferences

  • Locations I am interested in:
    Wallonia, Belgium
  • Work From Home:
    Yes, 2 to 5 days per week
  • Work Regime:
    BrightOwl freelancer :    24 Hours per week :    60% Free Per Month(in coming months)
  • International:
    No

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Balâtre, Jemeppe-sur-Sambre, Belgium

Others

Driving License
  • Yes

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