[Job Description]
1)Regulatory Affairs and Quality Assurance (RA/QA)
•Spearhead all procedure of MFDS registration and administrative work precisely and efficiently and that includes compiling registration submission, filing documents related, keeping, reporting, etc.
•Manage pre/intra/post-registration works for precise and efficient document control and data management according to SKL RA&QA SOP
•Support RA&QA Manager to ensure compliance of SKL QMS per MFDS regulations, ISO 13485 standards, and company standards by supporting the activities related to such as QMS documentation, internal and external audits, training, etc
2)Reimbursement
•Process and control overal medical reimbursement registration and code maintenance in line with government requirements and company strategy
•Spearhead all procedure of medical reimbursement registration and administrative work precisely and efficiently that includes compiling registration submission, filing documents related, keeping, reporting, etc
•Manage pre/intra/post-registration works for precise and efficient document control and data management
•Ensure to maintain NV‘s reimbursement codes list accurately including history and related information and references. And, Ensure all stakeholders can access this info at shared folder in any time when inquired
[자격조건]
- 4년제 대졸이상
- RA&QA 경력 6년 이상
- 영어 가능 필수
- 의료기 RA 관련 경력 보유자
[채용정보]
-정규직
-직급: 과장급 이상
-근무지: 서울 강남
-급여: 협의(업계 상위 수준)
-채용시 마감
[전형방법]
1차 서류전형
2차 면접전형
[제출서류]
-국/영문 이력서, 자기소개서
-이메일 지원 (ispark@r-star.co.kr/ 메일 제목: 이름_생년_성별_포지션명)
[담당자]
박인수 헤드헌터(02-6925-6713)
**서류 합격자에 한해 개별 연락 예정**