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First Name*

Last Name*

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Job type: Permanent

Discipline: Consultant / Specialist

Location: Korea, Republic of

A leading medical company in healthcare is seeking an enthusiastic Regulatory Affairs Specialist to be part of their team in South Korea. This is the ideal opportunity for a bright and dynamic individual to join an innovative team.

Job Description

Obtain registration of new products and be compliant and effective with all product safety activities in Korea
Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy.
Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.
Prepare, submit and support clinical trial applications including all related safety activities.
Maintain current knowledge of relevant regulations, including proposed and final regulations and provides regulatory affairs related information to other divisions and department
Assist regulatory country lead to provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications.
Assist regulatory country lead to develop and maintain standard operating procedures or local working practices.