About the Role
Primary Function of Position
The position is responsible for product safety information management, quality records
management, local labeling management. Also responsible for managing and implementing
necessary measures to comply with the Intuitive Quality Manual and related internal procedures
under ISK Quality Management System (“ISK QMS”).
Closely collaborate with Regulatory affairs, Commercial, Customer Service and SCM
Essential Job Duties
Product safety control
• Product complaint reportability assessment and/or approval
• Additional safety information collection from customers
• Product complaints, adverse event reporting to health authority designated organization
according to ISK QMS and Korea medical device regulations
• Health authority’s additional information requests management including drafting the
answers, subm...
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