Job Description Summary
Job Description
I. OVERVIEW OF THIS POSITION
The Regulatory Affairs Specialist is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements in Korea .
To support/ conduct all necessary registration activities in compliance with related regulations in worldwide as well as Korea.
II . DUTIES PERFORMED
1. Regulatory Work
- To perform/coordinate successful submissions and approval of products including IVD in accordance with IVD Act;
- To review ACR (Assessment Change Requirement) to maintain product licenses in Regulatory compliance;
- To monitor and analyze new and revised regulation to verify business impact;
- To communicate potential risks and mitigations associated with regulatory strateties to stakeholders.
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2. Compliance Work
- To support launching products regulatory review of label and IFU artworks and promotional materials;
- To review Research Use Only(RUO) reagents in accordance with K-REACH prior to import to Korea.
III . REQUIREMENTS
- B.S. or B.A. degree in biology, microbiology or bioscience (Science background will be preferred)
- New or Experienced (over 2yr experience in RA is preferred)
- Good at writing and translation skill in English
- Communicate clearly and effectively in both Korean and English
- Good social skills and ability to work in teams
- Proficiency with standard Windows and Office programs
※ Veterans and persons with disabilities are given preferential treatment in accordance with relevant laws.
Required Skills
Optional Skills
.
Primary Work Location
KOR South Korea - Seoul HQ
Additional Locations
Work Shift