┃회사소개
□ 고객사의 요청에 의해 기업명 비공개로 진행하며, 상세사항은 서류지원자에 한해 안내드리겠습니다.
┃모집분야
- 모집직종 : RA specialist
- 업무내용 : • 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.
┃자격사항
• Experience in regulatory for medical device industry less than 3 years
• Experience in negotiating with regulatory authorities
• Degree in science, engineering and law are preferred
• 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
** 매우 우수한 근무환경의 세계적인 외국계 기업에서 경력 쌓을 수 있으며, 경력 별 연봉 협의 가능합니다. 유관 경력 보유한 영어 상급자의 많은 지원 부탁 드립니다.
┃근무조건
- 급여조건 : 연 4,500만원 [세전/퇴직금 별도]
- 근무위치 : 서울 영등포구 국제금융로 (여의도역 인근)
- 근무시간 : 주 5일(월 ~ 금) 평일 09:00 ~ 18:00 - 채용형태 : 바른인사컨설팅 소속 1년 6개월 근무 후 퇴사 예정(산휴대체 포지션) / 실업급여 수령 가능
┃지원방법
- E-MAIL: seosj@baruninsa.com지원 온라인 입사지원 가능
- 적합자 지원시 마감될 수 있으므로 조기지원시 유리합니다.
※ 이력서 제목에 "(RA)-성명" 기재 必
┃문의처
- 연락처: 02-6951-2310
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