Eunee L.

Key Skills

Software

No software listed

Top Subject Matter

Legal Services & Contract Review

Regulatory Compliance & Risk Analysis

Legal Research & Document Analysis

Top Data Types

Document

Text

Top Task Types

Entity (NER) Classification

Freelancer Overview

Regulatory Affairs Assistant Manager. Brings 8+ years of professional experience across complex professional workflows, research, and quality-focused execution. Education includes Bachelor of Science, The Catholic University of Korea (2021). AI-training focus includes data types such as Medical DICOM and labeling workflows including Named Entity Recognition.

Labeling Experience

Regulatory Affairs Assistant Manager

Entity (NER) Classification

Spearheaded end-to-end Regulatory Affairs processes to secure and maintain import licenses for foreign medical devices under MFDS regulations. Prepared, reviewed, and submitted comprehensive technical documentation and dossiers required for product registration and market clearance in South Korea. Managed license lifecycle compliance, renewals, and proactive adaptation to evolving local regulatory frameworks while translating and localizing highly technical materials. • Led regulatory submissions and maintained import licensing compliance • Translated and localized IFUs, manuals, and product labels • Liaised between overseas manufacturers and local regulatory bodies • Ensured timely renewals and resolved documentation discrepancies

2022 - 2025

Education

Work History