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Summary

i am looking for a position of ra/qa manager in Medical Devices industry and my motivation is to assist in the development of safe products that meet the regulatory and customer needs, which i believe requires attention to every aspect of Product Development process, including Planning, traceability of user needs from development to v&v, Risk Assessment and design review, as well as post-market activities. although i very much enjoy my current position, also because it requires interaction with all stakeholders, which gives me the possibility to look at the projects from different perspectives, i am searching for a new challenge with more responsibility.

my experience includes the following:

Experiences

Current Experience

  • Client Manager Medical Devices EMEA / Medical Devices Assesor

    Homebased
    Since November 2017

Past Experience

  • Manager CE-IVD / QA

    January 2013 --- May 2017

    • quality representative responsible for qms maintenance • Planning and execution of internal audits, monitoring of the capa process, gap Analysis • responsible for the certification and registration of several annex ii IVD Medical DevicesCommunication with regulatory authorities (via distributors) for device clearance in non-eu markets • preparation and maintenance of technical files/design dossiers • input in all stages of the design process, including pre-market (design reviews) and post-market (pms and vigilance) activities • review and approval of regulatory contents of product labelling • regulatory and qa input into the management review process • Risk Management team Leader (ISO 14971) • dotted line manager for Laboratory personnel

  • Scientist R&D

    January 2011 --- January 2013
    Planning, evaluation and GMP-compliant Documentation of d&d effort for automated mdx Assays • establishing qc concept for a new FDA-conform max assay • Planning, evaluation and Documentation of V&V effort • input in development of multiplex PCR AssaysRisk Management team Member (iso 14971) • writing, revision and implementation of sops • experience with international standards and regulations: ISO 9001, ISO 13485, 98/79/ec, 21 cfr 820, glp/cGMP, etc. • experience with multi-site Quality System • work within a multi-national matrix organization • dotted line manager for Laboratory personnel

  • Security Officer for Medical Devices

    January 2009 --- January 2011
    • responsible for ce marking of IVD products, Communication with regulatory bodies, pms • compilation of technical Documentation, risk Analysis • writing and revision of sops in Compliance with 98/79/ec requirements

  • Project Manager

    January 2007 --- January 2011
    • responsible for the development of an automated poc mdx platform; coordination of project teams; reporting to the project funding body • collaboration on writing project proposals, acquisition of external funds • coordination and active participation in drafting patent Applications • supervision of students (bachelor and master theses) and interns

  • Deputy Head of Laboratory

    January 2007 --- January 2011
    • support of Diagnostic service: control and release of Lab result reports, customer support • experience with international regulations: ISO 9001, ISO 13485, 98/79/ec, glp

  • Research associate

    January 2005 --- January 2007
    • development of an automated point-of-care mdx platform for fast hiv load measurement in resource-limited settings • establishing fast, simple and cost-effective prep procedure for whole blood samples • experience with international standards and regulations: ISO 9001, ISO 13485, 98/79/ec, glp/cGMP

Personality

Self Assessment :
AdaptabilityProactivityProblem solvingAnalytical thinkingCritical thinkingStrategic thinkingInterest in knowledge

Knowledge

Self Assessment :
Medical devicesIn vitro diagnostics (IVD)Molecular DiagnosticsMicrobiologyProduct designProduct developmentVerificationValidationAnalytical Method ValidationStatistical Data AnalysisAutomationreal-time PCRChange ControlStability testsRisk ManagementProject ManagementCompliance with regulationsFDAGood Laboratory Practice (GLP)Good Manufacturing Practice (GMP)Quality Assurance (QA)Quality Management System (QMS)Root Cause Analysis (RCA)CAPARegulatory affairsRegistration of the productUnderstanding of regulatory guidelinesUnderstand how results translate to practiceUnderstand levels of research evidenceWriting Study Procedures and SOPs Scientific writing
LinkedIn Assessment :
molecular biologyInfectious diseasesIn vitro DiagnosticsPOC DiagnosticsReal-time qPCRMultiplex PCRProject ManagementProduct developmentV&VISO 9001ISO 13485ISO 1497121 CFR 820IVDDGMPLife Sciences

Education

  • Dr. rer. nat. in from Universität Osnabrück in 2005
  • Master of Science (MSc) in from University of Gdansk in 2000

Training and Certification

  • Internal Auditor ISO 13485 in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
German
Full Proficiency
Polish
Native
Russian
Elementary Proficiency
Dutch
Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    Quality Assurance (QA) Manager Regulatory Affairs Manager
  • Locations I am interested in:
    Groningen, Netherlands
  • Work From Home:
    Yes, 0 to 5 days per week
  • International:
    Yes

Area / Region

Maastricht, Netherlands

Others

Driving License
  • Yes

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