Job Description
**Job Description Summary**
RA coordinator will primarily support Regulatory Affairs (RA) activities for medical devices in Korea, ensuring compliance with MFDS regulations and timely product approvals. The role also includes limited support for Public Affairs (PA) and Market Access initiatives, such as reimbursement and health economics projects. Candidates must have strong knowledge of Korean regulatory frameworks and at least 1+ years of relevant experience in RA or related functions.
**Job Description**
**Main Responsibilities**
Regulatory Affairs (Main Focus)
+ Develop regulatory submission strategies and prepare dossiers for MFDS approval.
+ Review and manage responses to MFDS inquiries, ensuring strict compliance with Korean regulations.
+ Monitor regulatory changes in Korea and globally, providing outstanding recommendations to maintain compliance.
**Market Access & Limited Public Affairs Support**
+ Assist with rei...
RA coordinator will primarily support Regulatory Affairs (RA) activities for medical devices in Korea, ensuring compliance with MFDS regulations and timely product approvals. The role also includes limited support for Public Affairs (PA) and Market Access initiatives, such as reimbursement and health economics projects. Candidates must have strong knowledge of Korean regulatory frameworks and at least 1+ years of relevant experience in RA or related functions.
**Job Description**
**Main Responsibilities**
Regulatory Affairs (Main Focus)
+ Develop regulatory submission strategies and prepare dossiers for MFDS approval.
+ Review and manage responses to MFDS inquiries, ensuring strict compliance with Korean regulations.
+ Monitor regulatory changes in Korea and globally, providing outstanding recommendations to maintain compliance.
**Market Access & Limited Public Affairs Support**
+ Assist with rei...
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