Data Scientist & Project Manager
PhD in Medical Radiation Biology from the University of Duisburg-Essen, Germany.
Over 12 years of hands-on experience in bioinformatics, translational research, and large-scale project management. Formerly a Data Scientist and Project Coordinator at Friedrich Loeffler Institute and FactField GmbH in Germany. Core expertise includes single-cell RNA sequencing (scRNA-seq) pipeline development, multi-omics data integration, and end-to-end coordination of EU Horizon-funded projects. Certified Project Management Professional (PMP), holder of FELASA Category-B laboratory animal science qualification, and recipient of the Radiation Research Society (RRS) International Travel Award. Published over 10 peer-reviewed SCI papers in international journals including Cells and Cell Death Dis. Fluent in English (native level), German (C1), and Bengali (native), with strong cross-cultural research collaboration capabilities.
Prof. Dr. med
Chief Medical Scientist
Over 20 years of frontline clinical experience, Proficient in Chinese, English, and German. Chief Medical Director (Europe) and Head of the European Operations Center at Care-Real. Deep expertise in EU clinical-research regulation and medical-device studies; proven builder of pan-European hospital networks; successful track record engaging clinical monitor and clinical audits.
Doctor of Medicine (MD)
Chief Medical Director
20+ years medical-device clinical trials; 200+ protocols designed; 100+ product approvals supported; 30+ innovation programs led (biodegradable Mg-alloy implants; subcutaneous staplers; frameless stereotaxy; 3D-printed CMF implants; hip prostheses).
Regulatory Director
National Registered Auditor PMP, Project Management Professional
15 years of medical-device compliance and market-access experience. Formerly at a leading medical-device CRO; NMPA inspections, registration submissions, and clinical-expert meetings; designs multi-country compliance and market-access strategies; manages global device clinical trials.
Regulatory Affairs Manager Germany
Head of Regulatory Affairs at the European office.
National registered PRRC in Berlin, Düsseldof, Hamburg and Amsterdam. PRRC of 7 companies. Expert of MDR, FDA and Chinese Localization projects. Worked at multiple German manufacturers and consulting company as Head of QM/RA. Prepare, host and follow up on multiple Competent Authority inspections and Notified Body audits. Legal representative of multiple clinical investigation under MDR / IVDR
Regulatory Affairs Manager China
National Registered Auditor Senior Regulatory Affairs (RA) Expert
20 years in medical-device regulation; former global top-100 medtech professional. Expert in Class III NMPA and EU MDR requirements. Strong consulting record in submission strategy, on-site guidance, and QMS establishment and coaching.
