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Summary

Regulatory affairs specialist with a strong clinical background and internal auditing experience

Experiences

Current Experience

  • Senior Regulatory Affairs Consultant
    Since July 2013
    • Manage preparation of regulatory applications • Maintain regulatory files manually and electronically • Manage monthly invoicing • Maintain and develop client relationships • Attend client project meetings • Discuss and resolve technical issues with clients • Review of technical documentation ▪ Assist with the development and maintenance of the company’s Quality Assurance System (performing internal audits as per ISO 14155, reviewing/ writing SOPs) • Training of MedPass staff, investigational sites and sponsors on European and national regulations and guidance documents • Support team members

  • Regulatory Affairs Consultant
    Since January 2009
    • 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 protocol requirements • Geographical areas of specialisation: Austria, Belgium, France, Germany, Latvia, the Netherlands, Switzerland, and the UK

Past Experience

  • CRA and Senior CRA
    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 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 :
Clinical trialsMedical DevicesISO 14155European Medical Devices DirectivesTrainingDeclaration of HelsinkiISO 14971MultilingualEU regulatory submissionsClinical monitoringVigilanceSAE reportingRegulatory affairsRegulatory submissionsClinical researchCardiologyFDAGCPClinical DevelopmentBiotechnologyCTMSPharmaceutical IndustryLife SciencesRegulatory RequirementsOrthopedicDiabetesSOPCROProtocol

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 in Biology/ 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

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Regulatory Affairs Manager Senior Regulatory Affairs Specialist
  • Locations I am interested in:
    Belgium Brussels, Belgium Germany Paris, France
  • Work From Home:
    Yes, 2 to 4 days per week
  • International:
    Yes

Area / Region

Eriskirch, Germany

Others

Driving License
  • No