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 reimbursement submissions and pricing strategies as needed.
• Collaborate with internal teams and government agencies for market access initiatives.
• Support the development of Korea-specific health economic analyses in coordination with regional PA teams.

Continuous Development

• Build expertise in regulatory processes, internal systems, and healthcare policy trends.

Other Duties

• Perform additional tasks as assigned by managers.

Qualifications

We are looking for candidates who have the following qualifications and skills to succeed in this role:

Education and Experience

• A Bachelor’s degree or equivalent experience is required.
• At least 1 year of experience in Regulatory Affairs within the Medical industry is required.
• Proficient written and verbal communication in English and Korean, with the ability to manage collaborators in government agencies and Key Opinion Leaders (KOLs).

Skills and Abilities

• Orientation for detailed work products, with emphasis on accuracy and completeness.
• Good organizational and planning skills; driven to deliver outcomes.
• Effective analytical/problem-solving and time management skills.
• Good interpersonal and communication skills that enable teamwork and collaboration with other countries.
• Computer literacy (PC, Microsoft Word/Excel/PowerPoint).

Required Skills

Optional Skills

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Primary Work Location

KOR South Korea - Seoul HQ

Additional Locations

Work Shift