Sr. RA&PA Specialist

Job Description Summary

Job Description

P2-14313

• 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

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