JiJae Kim
Drug Safety & Regulatory Affairs Specialist
Changwon,42
Summary
Dynamic Regulatory Affairs Specialist with experience at DRGEM, adept at technical documentation and compliance for FDA and CE Marking. Proven track record in quality management and risk assessment, demonstrating strong analytical thinking and attention to detail. Successfully developed strategic regulatory roadmaps, enhancing market entry efficiency for medical devices.
Overview
6
6
years of professional experience
3
3
Certifications
1
1
Language
Work History
Regulatory Affairs Intern
DRGEM
Gwangmyeong, South Korea
09.2025 - 09.2025
- Technical File Review: Conducted comprehensive reviews of technical documentation required for international market clearances, specifically focusing on FDA 510(k) (USA) and CE Marking (EU) compliance.
- Safety & Performance Standards: Assisted in the verification of medical device safety standards, including IEC 60601-1 (General safety) and EMC (Electromagnetic compatibility), ensuring products met rigorous global regulatory requirements.
- Risk & Quality Management: Participated in reviewing radiation safety management protocols and quality control documents, ensuring data integrity and alignment with ISO 13485 and ISO 14971 (Risk Management).
- Compliance Documentation: Supported the preparation and auditing of technical files for diagnostic X-ray systems, developing a keen eye for detail in regulatory reporting and documentation.
Global Medical Device RA Specialist Career Camp
Comento
Remote
07.2025 - 08.2025
- Global Regulatory Comparative Analysis: Conducted a comprehensive comparative study of medical device regulations across South Korea (MFDS), USA (FDA), and Europe (EU MDR). Performed product classification and risk-grading for wearable medical devices (e.g., Apple Watch functions), ensuring adherence to country-specific safety standards.
- Technical File Preparation & Strategy: Developed core components of technical documentation, including 'Intended Use,' 'Performance Specifications,' and 'Testing Standards' for new medical products. Formulated strategic test plans and identified applicable international standards (ISO/IEC) to ensure regulatory compliance.
- Strategic Licensing & Market Entry Planning: Established end-to-end regulatory roadmaps, encompassing testing, documentation, and submission timelines. Proposed cost-reduction and schedule-optimization strategies for global market entry (US, EU, KR).
- Post-Market Surveillance (PMS) & Change Management: Analyzed procedures for post-launch changes and license renewals. Drafted technical documents for software updates and managed regulatory risk assessments for change notifications to global health authorities.
RA Specialist Intermediate Course
National Institute of Medical Device Safety Institution
Seoul
07.2025 - 08.2025
- Regulatory Framework Analysis: Conducted in-depth comparative analysis of MFDS (Korea), FDA (USA), and EU MDR (Europe) regulatory pathways to determine optimal market approval strategies.
- Technical File (TF) Mastery: Mastered the end-to-end preparation of Technical Files, including Essential Principles, Risk Management, and Clinical Evaluation Reports (CER).
- Lifecycle Management: Gained comprehensive understanding of the medical device lifecycle, from pre-market licensing to post-market surveillance (PMS) and quality management system (QMS) requirements.
- Compliance Validation: Demonstrated proficiency in interpreting complex international standards and guidelines to ensure regulatory compliance.
- Outcome: Awarded Professional Certification upon successful completion of the intensive intermediate curriculum.
Online English Instructor
Freelancer
Online (Remote)
03.2022 - Current
- High-Stakes Communication: Delivered specialized IELTS/PTE and Business English coaching to a diverse group of 15+ students, including overseas students in Sydney, Paris, and Texas, ensuring clear and accurate language delivery.
- Consultative Follow-up: Conducted detailed verbal and written feedback sessions to monitor progress and address specific learning gaps, similar to the medical case follow-up and triage processes required in PV services.
- Project Collaboration & Content Creation: Collaborated with native-speaking instructors to develop a specialized IELTS Writing digital curriculum; managed the entire lifecycle from topic selection and essay auditing to final editing, ensuring high-quality output.
- Service Excellence & Reliability: Successfully managed long-term client relationships and curriculum schedules, achieving high satisfaction rates that led to a 100% referral-based growth in student base.
- Group Facilitation: Organized and led professional English seminars for university cohorts, demonstrating strong leadership and the ability to explain complex linguistic concepts to diverse audiences.
Senior English Teacher
EnglishBorn Academy
Gimhae, South Korea
01.2021 - 02.2022
- Focus: Professional Translation, Cross-Cultural Communication, and Quality Assurance
- High-Stakes Communication & Triage: Delivered specialized IELTS/PTE and Business English coaching to a diverse group of 15+ international students (based in Sydney, Paris, Texas, etc.). Tailored complex curricula to meet specific regulatory (exam) standards and individual goals.
- Verbal Follow-up & Case Management: Conducted meticulous 1:1 feedback sessions to monitor progress and identify "pain points," analogous to the verbal follow-up and case triage processes required in Pharmacovigilance (PV) services.
- Collaborative Content Development (Project): Partnered with native-speaking instructors to lead the development of a specialized IELTS Writing digital curriculum. Managed the entire project lifecycle, including topic selection, essay auditing, and final editorial quality control.
- Documentation & Reporting: Provided detailed written assessments and progress reports for students, ensuring all instructional data was accurate, medically/linguistically significant, and aligned with international scoring guidelines.
- Group Training & Leadership: Organized and facilitated 2-hour group seminars for university cohorts, demonstrating an ability to translate and explain complex linguistic frameworks to diverse audiences.
English Instructor
Lingua English Academy
Changwon, South Korea
07.2020 - 12.2020
- Employed diverse teaching approaches to help students of all abilities understand material.
- Adapted lesson plans to accommodate different learning styles and abilities within the classroom setting for optimal comprehension of material covered.
Education
Bachelor of Science - Biomedical Engineering And Data Science
Pusan National University
04.2001 -
Skills
Strong communication skills
Quality Management
Documentation & Auditing
Statistical Analysis
Technical Translation
Attention to Detail
Time Management
Analytical Thinking
Certification
OPic
Timeline
RA Specialist Intermediate CourseTraining
09-2025
Regulatory Affairs Intern
DRGEM
09.2025 - 09.2025
Certified Global RA specialist career camp, Comento
08-2025
Global Medical Device RA Specialist Career Camp
Comento
07.2025 - 08.2025
RA Specialist Intermediate Course
National Institute of Medical Device Safety Institution
07.2025 - 08.2025
OPic
04-2025
Online English Instructor
Freelancer
03.2022 - Current
Senior English Teacher
EnglishBorn Academy
01.2021 - 02.2022
English Instructor
Lingua English Academy
07.2020 - 12.2020
Bachelor of Science - Biomedical Engineering And Data Science
Pusan National University
04.2001 -