Sanseul Kim

Summary
Regulatory Affairs professional in the cosmetics and medical device fields, responsible for domestic and international registrations, change notifications, post-market surveillance of Class III (Class 4) medical devices, and ISO-based quality compliance. Completed registrations across numerous countries and have hands-on experience preparing and revising technical documentation in accordance with EU MDR requirements.

1. Domestic Registration and Change Approvals

• Prepared and submitted domestic registration applications, managed review responses, drafted approval documents, and liaised with MOH/CRO to ensure compliance

2. International Registration

• Reviewed country-specific regulatory requirements and compiled registration dossiers to meet international standards for product approvals
• Completed registrations in numerous countries worldwide, including Mexico, Costa Rica, Qatar, and Saudi Arabia
• Led and completed online renewal reviews in Taiwan
• Established collaboration with a new CRO in Ukraine and independently navigated the online regulatory review process, resulting in successful product registration approval.

3. Post-Market Surveillance of High-Risk Medical Devices (EU MDR)

• Completed DNV training on post-market surveillance and directly authored the related documents
• Revised and supplemented documents in line with MDR requirements (CER, LS, PMCF, PSUR, and PMS Report)
• Developed the implant card, an essential requirement for implantable devices, in compliance with MDR specifications

4. Quality and Standards Compliance

• Conducted a gap analysis for the 2026 revision of ISO 10993-1

5. Collaborated with multiple ODM/OEM partners to complete registrations in Latin America and CIS countries

• Coordinated with multiple ODM/OEM partners to finalize registrations across Latin America and CIS countries, including Russia, enhancing market access.

Summary
Conducted research in a dermatology laboratory under government-funded projects, participating in the overall R&D process from candidate compound screening to preclinical studies using cell-based and animal experiments.

• Performed screening in government-funded research projects to identify and select effective therapeutic candidates
• Established and maintained cell culture systems, verifying efficacy and mechanism of action of candidate compounds using molecular biology techniques such as Western blot, PCR, and qPCR
• Conducted preclinical studies with animal models to evaluate in vivo efficacy of candidate compounds
• Compiled the research findings and presented them as a poster at the KSID (Korean Society for Investigative Dermatology) Research Camp

Summary
Worked in a hematology-oncology department supporting Clinical Research Coordinator (CRC) and Clinical Research Associate (CRA) activities, while also performing basic research experiments and managing government-funded project accounting, building practical experience across both clinical and research settings.

• Supported CRC duties in clinical trial operations, managing subject schedules, facilitating informed consent, and completing Case Report Forms (CRFs)
• Assisted with CRA duties, including preparing for monitoring visits, organizing essential documents, and reviewing source documents
• Collected patient samples and operated and managed the sample bank
• Managed expense settlements for government-funded research projects, compiling budget records and preparing settlement reports to ensure compliance and financial accuracy