Safety Control Associate (Fixed Term)

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...