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

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