Caroline has over 20 years of experience in Quality and Regulattory Affairs across multiple healthcare-related industries including Pharmaceuticals, Laboratory Testing and IVD Medical Devices, specifically Near-Patient Testing. Caroline is currently responsible for leading Quality Assurance, Quality Control, Product Risk Management and Regulatory Affairs for QuantuMDx Group and is the designated Person Responsible for Regulatory Compliance, ensuring the Company maintains an accurate view of the changing global regulatory landscape.
Caroline has made successful submissions globally with approvals and registrations in UK, USA, Belgium, France, Italy, Greece and Qatar with applications underway with US FDA and SFDA. Caroline is competent with WHO PQ, WHO EUL, US EUA and MHRA derogation for emergency use pathways, has significant experience in IVDD, MDD, MDR, IVDR, GAMP5, 21CFR820 and standards including ISO 13485, ISO 14971, ISO 62366, IEC 62304, ISO 20916 and ISO 23640. Finally, Caroline is an experienced mentor and supporter of Women in Leadership Roles.