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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:

  • CE marking of several Annex II and general IVD medical devices (as quality representative)
  • assistance in obtaining regulatory approval in the US (510(k) and PMA; as R&D member)
  • preparation and maintenance of DHF/technical documentation and other regulatory documents required for product registration
  • communication with notified bodies and regulatory authorities
  • experience in development of IVD products, incl. POC devices, for EU and US market, development and validation of QC programs, design transfer
  • planning, evaluation and documentation of V&V studies.
  • participation in numerous risk management meetings/reviews
  • planning and execution of design changes
  • evaluation of QMS effectiveness, monitoring and measurement (KPIs)
  • CAPA process
  • planning and execution of internal audits.


Current Experience

  • Manager CE-IVD / QA
    Since January 2013
    • 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 devices • Communication 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

Past Experience

  • 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 assays • Risk 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


Self Assessment :
AdaptabilityProactivityProblem solvingAnalytical thinkingCritical thinkingStrategic thinkingInterest in 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


  • 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 Certification


BrightOwl Assessment:
Self Assessment:
Full Proficiency
Full Proficiency
Elementary Proficiency
Elementary Proficiency

Work Preferences

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

Area / Region

Maastricht, Netherlands


Driving License
  • Yes