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Summary

i have worked 12 years in the Medical Device industry. through my extensive knowledge in Clinical, quality, regulatory and technical activities associated with Medical Devices, i am able to apply a holistic approach to strategic Consulting. i am convinced that knowledge is a corner stone of a company. i have been very successful at transforming this all-round expertise into solid and comprehensible internal and external trainings. i have a proven track record acquired through continual client engagement and successful Project Management of breakthrough Medical Device technologies across a wide range of Therapeutic Areas.

Medicine is something wonderful, but it wouldn't be nothing without the patient. i am a strong defender of the declaration of helsinki. one of my favourite quotes is “i never lose. i either win or learn”.

Experiences

Current Experience

  • Manager of Strategic Consulting

    Tervuren, Belgium
    Since December 2017

    help clients determine the most efficient and cost effective pathway to Medical Device regulatory approval in europe.

    key tasks: management of the strategic Consulting department; notified body liaison; perform/ coordinate regulatory and technical reviews of technical Documentation (e.g. cep, cer, pmsp/ pmsr, rm, bench Testing, ib, csr) to be submitted to authorities for the purpose of placing devices on the eu market or for Clinical investigations; provide Training on Medical Device regulation to internal staff and to clients; participate in the development and maintenance of the qms.

    Help clients determine the most efficient and cost effective pathway to medical device regulatory approval in Europe.

    Key tasks: management of the strategic consulting department; Notified Body liaison; perform/ coordinate regulatory and technical reviews of technical documentation (e.g. CEP, CER, PMSP/ PMSR, RM, bench testing, IB, CSR) to be submitted to Authorities for the purpose of placing devices on the EU market or for clinical investigations; provide training on medical device regulation to internal staff and to clients; participate in the development and maintenance of the QMS.

Past Experience

  • Senior Regulatory Affairs Consultant Eriskirch, Germany and Tervuren, Belgium

    July 2013 --- November 2017
    provide in-depth, up to date, country by country knowledge that is crucial to develop effective submission strategies to get a product on the market and keep it there. key tasks: coordination of regulatory submissions (pre- and post-market Clinical trials) in accordance with applicable regulations; competent authority and Ethics committee liaison; provide advice to staff and clients concerning regulations and national requirements related to Clinical research and actions to be taken to ensure Regulatory Compliance; regulatory review and approval of key documents (e.g. cip, pic, ib, labelling, ifu); provide Training on Medical Devices regulations to internal staff and to clients; participate in the development and maintenance of the qms.

  • Regulatory Affairs Consultant Paris, France

    January 2009 --- June 2013
    • preparation of regulatory submissions to ethic committees and competent authorities in accordance with the mdd (ec directive 93/42/eec), aimd (ec directive 90/385/eec), and the ISO 14155 • participation in regulatory Strategy Consulting (risk benefit Analysis, placing on the market etc.) • leading interactions with the european competent authorities and ethic committees on behalf of clients • participation in european regulatory surveillance (directives, insurance legislation, reporting of serious Adverse Events) • design and review of protocols, instructions for use, labeling, patient information and consent forms, ibs, and crfs • ability to manage regulatory projects from regulatory Strategy to submission, taking into consideration all regulatory requirements, client expectations and project timelines • Training of medpass staff and clients on european and national regulations and guidance documents • Training of study coordinators and investigators regarding european regulations (germany) and specific science)" rel="nofollow">Protocol requirements • geographical areas of specialisation: austria, belgium, france, germany, latvia, the netherlands, switzerland, and the uk

  • Senior Clinical Research Associate (CRA) Paris, France

    April 2007 --- December 2008
    • conduct of routine site visits including initiation, Interim and close-out visits and preparation of reports, management of sae’s, and overall management of Clinical sites • review and design of protocols, crfs, and patient information and consent forms • Training of study-coordinators and investigators regarding european regulations and specific science)" rel="nofollow">Protocol requirements • experience in Clinical investigations of the following Medical Devices: o Cardiology (percutaneous aortic valve prosthesis, transapical aortic valve prosthesis, percutaneous pacemaker, stents) o weight loss & Diabetes (gastro-intestinal implant) o Neurology (aortic catheter to improve cerebral perfusion in acute ischemic stroke) o Orthopedics (disc arthroplasty system in degenerative disc disease, dural sealant system as an adjunct to suture dural repair during cranial and spine Surgery, acl replacement devices)

  • Project leader – Junior scientist

    April 2005 --- April 2007
    • scientific expertise regarding the use of pathogens and gmos in laboratories, greenhouses, animal facilities, large-scale units and Hospital rooms • assessment (case-by-case basis) of the risk to human Health and the environment of activities involving gmos and/ or pathogens • scientific expertise regarding emergency plans for activities involving gmos and/ or pathogens • transmission of knowledge to a broad public • drawing up guidelines, articles

Personality

Self Assessment :
Attention to detailAssertivenessAuthenticityCommunicativeCompetitivenessCritical thinkingCuriosityEfficiencyFlexibilityIndependenceIndividualityInterest in knowledgeProactivityProblem solvingReaction to stressResponsibilitySelf-confidenceSelf-disciplineStrategic thinkingTrust

Knowledge

LinkedIn Assessment :
Medical DevicesRegulatory affairsClinical trialsRegulatory submissionsISO 14155European Medical Devices DirectivesDeclaration of HelsinkiISO 14971MultilingualEU regulatory submissionsSAE reportingClinical researchCardiologyRegulatory RequirementsSOPTrainingClinical monitoringVigilanceFDAGCPClinical DevelopmentBiotechnologyCTMSPharmaceutical IndustryLife SciencesOrthopedicDiabetesCROProtocolISO 13485Internal AuditStandard Operating Procedure (SOP)CRO managementGood Clinical Practice (GCP)

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Create SOPs Develop clinical trial protocols Guide students Interact with nurses Interact with physicians Monitor a clinical studyAdverse event reportingApprove consent documentsApprove monitoring reportsApprove patient informationArchive study documentsAssign activitiesAssist study siteAttend seminarsCoach staffCommunicate with investigatorCommunicate with sponsorConduct close-out visitsConduct monitor visitsConduct site initiationConfirm protocol complianceContract approvalControl protocol versionsControl dataCoordinate with the ethics commiteecoordinating research projectsCreate study documentsDesign protocolDesign study documentsDesign subject consent formDevelop regulatory strategyDirect co-workersDocument adverse eventsEnsure good clinical practice (GCP)Ethics committee applicationEthics committee submissionsFollow-up of internal auditsGuide staffGenerate regulatory submissions Handle callsInformed consent processInteract with ethics committeeInteract with physiciansLabeling compliance with local regulationsManage clinical trial files/documentsMonitor clinical trials Negotiate budget Monitoring subject complianceNegotiate payment schedulesMonitor dataOral presentationOrganise meetingsPrepare internal auditsRegulatory documentationRegulatory submissions Search literature on clinical trialsReport serious adverse events (SAE)Report non-compliance incidentsResolves queriesRespond to audit findingsReview monitoring reportsReview queriesReview study protocolsSolve problemsTrain off site staffTrain on site staffTranslate protocol into packaging and labeling requirementsWriting regulatory documentsWritten presentation

Education

  • Master’s degree in Biology/ in Major in Human Biology from VUB in 2003

Training and Certification

  • An Overview of ISO 14971 & How To Apply a “Risk Based Approach” to Your QMS Processes to Address the Upcoming ISO 13485 Changes (by Jon Speer, greenlight.guru) in 2015 Training
  • How to Prepare a 510(k) Submission for the FDA? (Robert Packard) in 2015 Training
  • The Impact of New CE Marking Rules in Europe (by Bassil Akra, TUV SUD) in 2015 Training
  • The Regulatory Framework for Clinical Investigations with Medical Devices in the European Union (EU) - today and tomorrow? (by Dr. Susanne Gerbl-Rieger, Chair EUCROF WG Medical Devices) in 2015 Training
  • Time’s Up! Mandatory Unique Device Identification Starts September 2015 (Reed Tech) in 2015 Training
  • CNOM/CNIL/Loi de la transparence (MedPass) in 2014 Training
  • Comment changer d’organisme notifié (ON) pour le LNE/G-MED? (by LNE) in 2014 Training
  • MRI compatibility of medical devices (by LNE) in 2014 Training
  • Clinical evaluation (MedPass) in 2013 Training
  • MPG online training (by GCP service) in 2013 Training
  • SAE and Vigilance reporting (MedPass) in 2013 Training
  • The Notified Body's role in Medical Device Certification (by LNE) in 2012 Training
  • Combined products: Class III Medical Devices incorporating a medicinal product – regulatory framework and consulting and evaluation procedure (by ANSM) in 2010 Training
  • European regulations regarding medical devices (by LNE) in 2010 Training
  • Klinische Prüfung von Medizinprodukten und Überwachung - Konsequenzen der 4. MPG-Novelle (by BVMed) in 2010 Training
  • Risk analysis training (MedPass) in 2010 Training
  • German courses (individual tuition - MedPass) in 2009 Training
  • Amendment to MDD and AIMD (2007/47/EC) (MedPass) in 2008 Training
  • Common Informed Consent Form issues during monitoring visits (MedPass) in 2008 Training
  • Procedure Selection – Qualification of sites (MedPass) in 2008 Training
  • ISO 14155 (MedPass) in 2007 Training
  • Medical Device Directive (93/42 CEE) (MedPass) in 2007 Training
  • Monitoring adverse events in Cardiology (MedPass) in 2007 Training
  • Monitoring AEs/SAEs in medical device trials (MedPass) in 2007 Training
  • Languages

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

Work Preferences

  • Positions I am interested in:
    Regulatory Affairs Manager Senior Regulatory Affairs Specialist Director Regulatory Affairs Lead Consultant Senior Consultant Senior Strategy Consultant
  • Locations I am interested in:
    Belgium Brussels, Belgium
  • Work From Home:
    Yes, 2 to 3 days per week
  • International:
    Yes

Area / Region

Tervuren, Belgium

Others

Driving License
  • Yes

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