Roman Oravec, MSc.

Founder & Chief Scientific Officer

Roman Oravec is a regulatory, quality and clinical operations professional with scientific training in Human Molecular Biology and industry experience since 2001. He combines 20+ years in clinical operations/pharmacovigilance with 15+ years in regulatory operations covering Pharma / MD / IVD and regulated clinical development. He currently leads IVD regulatory strategy and technical documentation responsibilities as Chief Regulatory Officer at MultiplexDX (since 2020) and supports MDR remediation and audit readiness work for manufacturers.

Selected Focus Areas

• IVD registration strategy, TD preparation and validation leadership
• QMS readiness across ISO 13485 / ISO 15189 / ISO 9001 and 21 CFR 820
• MDR remediation: documentation and process remediation, audit readiness
• Broad clinical operations delivery (Phase I–IV / NIS) and medical writing (IMPD/CTP/CSR)

Languages: Slovak (native), Czech (fluent), English (fluent), German (intermediate), Russian (basic)