Kayla Kim
Medynus
Irvine,CA
3
Languages
Knowledgeable office manager with comprehensive background in regulatory compliance and submissions. Proven ability to support regulatory strategies and manage documentation processes efficiently. Demonstrated expertise in navigating regulatory requirements and fostering cross-functional collaboration.
Work History
Office Manager (Interim QA/RA Responsibilities)
2 Months- Managed inventory of office supplies, supporting availability and cost efficiency.
- Coordinated meeting schedules and appointments, enhancing team productivity.
- Assisted with onboarding processes for new employees, promoting seamless integration into company culture.
- Improved filing systems, boosting document retrieval efficiency.
- Acted as interim lead for QA and RA functions during managerial absences.
- Oversaw maintenance of quality management systems in compliance with FDA, MFDS, and ISO 13485 regulations.
- Managed regulatory documentation, including registration, submissions, and renewals, in alignment with regulatory strategies.
- Participated in internal and external audits, as well as regulatory inspections from FDA, MFDS, and clients.
Education
Master of Science - Regulatory Affairs
Bachelor of Arts - Psychology
Skills
Office management
Customer service
Organizational skills
Office administration
Regulatory submissions
Labeling and packaging
CAPA management
Post-marketing surveillance
Medical device regulations
Risk management
FDA regulations
ISO standards
Quality assurance
Quality assurance controls
Languages
Korean
Native or Bilingual
English
Native or Bilingual
Japanese
Elementary
Timeline
Office Manager (Interim QA/RA Responsibilities)
Medynus
06.2026 - CurrentRead More
Northeastern University
Master of Science from Regulatory Affairs
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University of California, Riverside
Bachelor of Arts from Psychology
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