Jihye M.

Medical Device Clinical PM & Regulatory Affairs Specialist

I am a South Korea-based professional with 16+ years of total experience across healthcare, beauty, professional training, and content development, including nearly five years in aesthetic medical device clinical project management and regulatory affairs. My experience includes managing Korean clinical studies, preparing and reviewing clinical and regulatory documentation, coordinating CROs and clinical sites, reviewing clinical data and safety information, and supporting MFDS and EU MDR activities. I have worked with protocols, CRFs, ICFs, EDC systems, monitoring documentation, AE/SAE review, PMS, PMCF, and PSUR documentation. I can support clients with: • Korean-language AI evaluation and professional benchmark task creation • Medical device clinical and regulatory document review • Medical and technical writing, research, and fact-checking • Project plans, SOPs, training materials, presentations, and evaluation rubrics • Korean localization and quality review for healthcare and professional content • Structured data annotation and guideline-based content evaluation I also have extensive experience developing curricula, training manuals, presentations, digital learning content, and product education for healthcare and beauty professionals. I deliver clear, accurate, and well-structured work while maintaining confidentiality and following detailed guidelines. I use only client-authorized, public, or legally usable information and never disclose confidential materials from previous employers.