-Coordinate with distributor/ file notification to inform regulatory authorities of Indonesia regarding changes in registered products.
-As and when requested carry out other regulatory/ quality tasks delegated by the manager or senior officers of Flexicare Indonesia.
-Support information request for tender in Indonesia
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Requirement:
-Minimum 1 - 2 years of work experience in Regulatory Affairs for medical device products.
-Possess at least a Bachelor’s Degree in Science from an accredited university.
-Excellent verbal and written communication skills with strong English language proficiency.
-Strong computer skills.
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-Exceptional ability to work independently with minimal supervision, effectively organize, prioritize, and manage multiple projects.
-Positive attitude, strong attention to detail, and ability to solve problems independently.
-Comprehensive understanding of regulatory activities and how they impact other products and/or processes.
-Knowledge of quality management systems, technical file compilation, and Indonesia medical device regulatory requirement