풀타임
설명
채용제목 Regulatory Affairs_Sr. RAC Specialist (지원마감) 회사소개 외국계 의료기기회사 업무내용/자격요건 담당직무
1. Initiate, track and facilitate new product registrations in Korea and achieve on-time approvals
2. Review and approve the Korean labeling and promotional materials
3. Support WW export business for regulatory issues and handle the product registration related activities in WW as well as Korea for responsible products
4. Establish and maintain good relationship for efficient registration process and perform regulatory compliance activities with KFDA, KTR(Testing agency) etc. for reporting of adverse event/recall and Post Market Surveillance
5. Proactively renew licenses to avoid business interruptions
6. Coordinate compiling documents and perform all regulatory assessments with WW RA
7. Monitor regulatory environment changes, and provide impact analysis plus action plans to ensure compliance interaction with local regulatory authorities, experts, and industry groups
8. Provide regulatory input to the relevant functions (Marketing, Sales,etc.) for developing new projects and variation in existing products
9. Communicate local environment change and registration status to local, regional, and global stakeholders
[자격요건]
1. University de
