본문
- Mainly Product License Approval for new and amendment on time
- Prepares regulatory documents for product submissions. Acquires
information from appropriate technical groups and project personnel which
addresses performance of medical devices, instrument. Assures adequate
documentation exists for product claims and directs timely review of
regulatory documents.
- Demonstrates continuous pursuit of regulatory knowledge to
obtain experience and expertise in product submissions and regulatory
topics
- Strategic communication skill and ability with team, MFDS
officer and Business partner
- Strategic and meticulous mindset is preferred
- Minimum 4~7 years prior experience working on product
regulatory submissions.
- Fully understand new and revised Medical device Act
|
