¡¤ Account for the assigned
new registration & maintenance projects and updates of existing product
licenses
¡¤ Anticipate regulatory
environmental changes and take appropriate actions to cope with the situation
¡¤ Ensure all regulatory
compliance activities and fulfill responsibilities to secure business
continuity, including KGMP
certificates, labeling, approval variation, annual
reporting, and product renewal, in accordance with country and global
company
regulatory requirements
¡¤ Comply with all legal,
regulatory, and ethical business requirements while executing the assigned
roles and
responsibilities, as defined in the local regulations and Corporate
procedures.
¡¤ Develop and lead local
language labeling & promotional material review.
¡¤ Support internal tasks
assigned by the line manager.
¡¤ Actively participate in
industry meetings and MFDS explanatory conferences, share the information from
these
meetings with the team and other departments
¡¤ Have experience with UDI (unique device
identifier), UDI database, and in-depth knowledge of MFDS requirements
KNOWLEDGE, SKILLS & EXPERIENCE
- University/Bachelor¡¯s
Degree and Major in science or engineering preferred
- More
than 3 years¡¯ experience in regulatory affairs of medical device
- Specialized
knowledge of regulatory activities
- Experience with KGMP is favoured
COMPETENCIES
- Fluent in English
- Ability to manage multiple and varied tasks in a
fast-moving environment
- Strong sense of responsibility on meeting due/target
- Good interpersonal skills and proven ability to
contribute to a team environment
- No reason for
disqualification for oversea travels
Other [Important]
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