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| 외국계 의료기기 회사 RA Specialist (지원마감) | |
|---|---|
| 회사소개 | 외국계 의료기기 |
| 업무내용 / 자격요건 |
[담당업무] Position Description: Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Leads or compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking / control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects ? from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. [자격요건] Requirements - At least 3 years Regulatory Affairs experience in medical devices or pharmaceutical industry - RAC (Regulatory Affairs Certificate) preferred - Experience of Combination Product Approval or New Drug Approval is preferred - Excellent verbal and written English communication and interpersonal skills Attributes - Customer focused - Professional presentation - Systematic and detail minded - Can work autonomously but is also a team player - Self-motivated and positive - Outgoing and friendly - “can do” attitude - Well organized, quick thinker, creative - Responds to deadlines and priorities - Aptitude for technology - Empathetic, good listener - gives recognition where it's due - Resilient, persistent [전형절차] 서류전형 - 컨설턴트 인터뷰 - 기업 면접 [제출서류] 국,영문이력서(경력기술서 포함) [직무분야] RA [경력년수] 3~5년 [기본연봉] 협의 [참고사항] Reporting:Sr. Regulatory Affairs Supervisor [지원방법] 하단의 회원 온라인지원 혹은 kd@cnscout.co.kr 로 이력서를 보내 주시면 검토 후 헤드헌팅을 진행하여 드리겠습니다. |
| 기타사항 |
학력:대졸이상, 외국어:영어 직급/직책:국문직급없음 근무지:강남 |
| 담당자 |
담당컨설턴트: 강두견 컨설턴트 연락처: 010-8543-1135 / 이메일: kd@cnscout.co.kr |
