Berlare, Flemish Region, Belgium
Regulatory affairs consultant and ISO 13485 lead auditor for in vitro diagnostic medical devices (IVD), specialized in European Regulation. Consultancy services for IVD manufacturers who want to bring their devices to the (European) market, pharma/biotech companies that need to include non-CE marked IVDs in European clinical trials, and EU laboratories that seek compliance with the European IVD Regulation (IVDR). Consultancy services include: • Regulatory strategy to bring devices on the market • Quality Management system compliance with ISO 13485 and IVDR • Risk management, usability engineering, performance evaluation and post-market surveillance • Technical Documentation in compliance with IVDR • Support with Technical Documentation submissions to notified bodies for device conformity assessment • IVD performance evaluation studies for combined (device/drug) studies in the EU • IVDR Article 5(5) compliance for EU laboratories/health institutions Co-Chair of the RAPS Belgium Local Networking Group (LNG), a networking group founded in 2024 within the RAPS (Regulatory Affairs Professionals Society) community. Biomedical scientist by training and professional experience with hands-on and managing experience in various aspects of the medical laboratory, CE-marked IVDs, and in-house developed tests for clinical drug trials.
Regulatory compliance of In Vitro Diagnostic (IVD) Medical Devices with EU Regulation 2017/746 (IVD-R) Consultancy, regulatory compliance gap assessment, and technical file writing of Class A, Class B, Class C and Class D IVD devices. Consultancy and technical writing for IVD clinical evidence (Scientific Validity, Analytical Performance and Clinical Performance). Focus on flow cytometry and routine clinical diagnostic devices.
Responsible for global lab testing capabilities and reporting for clinical drug trials. Custom assay development and global harmonization (QC) of routine diagnostic tests. Implementation of the laboratory component of clinical study protocols. CAPA management and interlaboratory QA oversight. Works closely with Clinical Operations (clients), Project Management (internally), QA (internally) and Sales (internally). Business development activities with pharma and biotech clients. The Head of Science Department reports to the CEO.
Custom flow cytometry assay development and validation, global assay roll-out, result reporting, and global QC policy. Coordination of global flow cytometry activities, as developed and performed for clinical drug trials. Works closely with Clinical Operations (clients) and Project Management (internally). CAPA management, internal EN ISO 15189 auditing Business development activities with global pharma and biotech clients The Flow Cytometry Scientific Liaison reports to the CSO.
Head of Customer Service Department Responsible for logistics, medical secretariat, phlebotomy and doctor e-support in EN ISO 15189 accredited environment The Heads of Laboratory Departments report to the Medical Director