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[Cook Medical] RA Specialist(5-7년차/대리-과장/정규직)
작성자 최귀은 조회수 464 작성일 2021-05-18 오후 4:56:00

Job Description

The position reports to RA Director of Korea and primary responsibilities include, but are not limited to:
- To get MFDS approvals to facilitate and ensure smooth and timely introduction of new products according to SBU needs.
- Provide status report and submission and approval status of registration to RA Director.
- Develop the appropriate strategies and proactively take an action for post-market approval / re-evaluation / KGMP.
- Establishes and maintains reasonable and responsible regulatory climates locally through good networking (e.g. with other cross-functional/sector/category/regional/colleagues).
- Work with Cook manufacturers to provide strategy and multiple options for meeting regulatory requirements (Provide “can do” solutions, not “cannot do” roadblocks)
- Write and review Regulatory Submissions professionally.
- Train stakeholders on Korea regulatory requirements and regulation such as sales team, Cook manufacturers, etc.
-  Negotiate with local authorities on behalf of Cook objectives
-  Collaborate with Quality and Reimbursement team for all submissions where applicable
- Actively participate in industry activities to influence favorable regulatory policies for company interest.
- Learn the Cook Group vision and ensure regulatory compliance.

Job Requirements

Experience
- 5-7 years of medical device RA experience (In Korean title, Daeri - Gwajang position)
- Experience in regulatory for medical device industry
- Experience in negotiating with regulatory authorities
- Experience in making submission document and getting approval

Education
- Degree in science, engineering and law are preferred

Personal Attributes
- 5-7 year RA Working experience in foreign medical device companies
- Fluent in English, both spoken and written
- (Capability to Train overseas manufacturers, attend/lead conference calls with overseas manufacturers)
- Experience working for multi-national companies
- Interpersonal Skills and Team Player
- Organizational Skills
- Positive attitude
- ? Willingness to improve job related knowledge throughout constant self-study on local/overseas regulation and active participation to industry activities.
- Organized, good management and planning skills
- Ability to work closely with people at all levels
- Excellent communication skills
- Strategic thinker with excellent time management skills
- Self-motivating


Guidelines for Applicants

전형방법 :

1차 서류전형
2차 면접전형

제출서류 :

한글이력서, 영문이력서 를 하나의 word 파일로 제출

접수방법 : 이메일 : HR-Korea@cookmedical.com 
담당자, 연락처, 이메일, 첨부파일
업체명 쿡메디칼코리아
지역 여의도
고용형태 정규직
학력 대졸
신입/경력 경력
지원방법 이메일 접수
접수기간 시작일 2021-05-18
접수기간 마감일 2021-06-13
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