Preparation and review of documents on a daily basis
• Perform translation of the documents from English to Korean for government licensing
• Handle data management, monitor and tracking/control systems, and ensure all materials are available required in the submission, license renewal and annual registrations
• Ensure company is following the protocol/standard procedures for regulatory compliance
• Communicate with internal/external stakeholders including the marketing team and government authorities in regulatory submission
경력 및 자격요건
• Bachelor's Degree Required in Medical/ biological science/ nursing or equivalent field
• Min 3 years of experience in a Regulatory Affairs role, strong preference in medical devices
• Excellent stakeholder relationship management
• Outstanding communication and interpersonal skills
• Strong ability to work well within a team and autonomously
• Achievement oriented and ability to drive results with the highest quality standards
• Computer skills (excellent knowledge of MS Office products).
• High attention to detail and accuracy
• Good prioritization and organizational skills.
• Excellent problem-solving skills
• Bi-lingual proficiency in English and Korean language
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5015
yhw@nterway.com
