As Director Authorized Representative Operations she is responsible for the representation of non-EU IVD and MD manufacturers based in the US, Asia and Australia (product notifications, cooperation with competent authorities on vigilance cases, provision of legalized certificates of free sales).  

Her expertise includes i.e.:

  • Regulatory Compliance
    (IVD Directive 98/79/EC and IVDR 2017/746)
  • Writing Scientific Validity Reports including systematic literature review
  • Complaint Management
    Development of an efficient cross regional Complaint Management System and procedures as well as functioning as SAP Business Process Owner for the complaint management tool
  • Vigilance Reporting in accordance with MEDDEV Guidelines
  • Development of an EMEA Regulatory Strategy for entire product pipeline in collaboration with sales and marketing
  • Product Management
    Product lifecycle management from product launch to product discontinuation
  • Managing cross functional and cross-regional projects


ISO Certified
ISO 13485 and ISO 27001


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