Medical Manager
PhD in Medical Biology, University of Duisburg-Essen, Germany
Worked on medical research at the University Hospital Essen and the West German Proton Therapy Centre (WPE). Currently focused on medical device clinical trial research, leading clinical trial protocol development, clinical evaluation writing and EU compliance implementation; drawing on expertise in evidence-based medicine and data analysis to provide medical support across the full life cycle of medical device products from R&D to market launch.
Deputy Director, Medical Department
Master of Medicine
Master of Medicine Over 16 years of experience in the medical device industry and 7 years of experience in medical device clinical trial projects. Formerly worked at Suzhou Innomed Medical Device Co., Ltd., responsible for clinical trials and equivalent-d
Data Scientist & Project Manager
PhD in Medical Radiation Biology from the University of Duisburg-Essen, Germany.
Possessing over 12 years of hands-on experience in bioinformatics, translational research and large-scale project management. Previously worked at the Fritz Lipmann Institute in Germany and FactField GmbH as a Data Scientist and Lead Project Coordinator. Core expertise includes the construction of single-cell RNA-seq analysis pipelines, multi-omics data integration, and end-to-end coordination and execution of EU Horizon-funded projects.
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.
