의료용품 도매업 업종 기업으로 의료용구,위생용품(수습용봉합사,바늘카데타,기타의료용구) 도매,무역 사업을 하는 외국인 투자기업기업이며, 자본금은 28억 4,000만원 매출액은 2,475억 9,145만원 사원수는 282명입니다.
Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
1) Position: Regulatory Affairs Specialist
2) Sector: Medical Devices (존슨앤드존슨 메디칼)
3) Location: Yongsan, Seoul
4) Work Type: Fixed Term
[Summary]
Responsible for finalizing the preparation of Standard Technical Dossier (STED) for initial registrations, product changes, re-registrations and renewals to support Medical Devices products from multiple business units in APAC countries. Assists with preparing necessary information for regulatory submission and prepares general local documentation, forms, and transactions required for final submission in countries as assigned.
[Responsibilities]
1) Compiles information and documentation for routine submissions to APAC local countries regulatory bodies for multiple business units.
2) Ensures collection of all related documentation as required to receive agency approvals or in response to agency requests.
3) Provides basic information to various departments regarding submission requirements and standards to facilitate efficient processing by agencies.
4) Organizes and prioritizes submissions that need review to ensure they meet paper and electronic regulatory submission standards, policies and operating procedure requirements.
5) Organizes and prioritizes regulatory submissions to be reviewed for compliance with submission standards.
6) Ensures compliance with regulatory agency regulations and interpretations.
7) Prepares responses to regulatory agencies' questions and other correspondence as requested.
8) Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
9) Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
10) Provides solutions to a variety of problems of moderate scope and complexity.
[Requirements]
- University/Bachelors degree or equivalent is required. Degree within a technical related discipline is preferred.
- Min 2 years of related experience in Medical Devices is highly preferred
- Excellent communication skills (verbal and written) in English
[JD 확인 및 지원 방법]
www.careers.jnj.com -> Requisition number 1805676575W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”
[제출 서류]
영문 자유 양식의 이력서/자기소개서
[서류 마감일]
채용시 마감
[유의사항]
- 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비 하시기 바랍니다.
- 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연 될 수 있습니다.
- 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다. www.careers.jnj.com
Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
1) Position: Regulatory Affairs Specialist
2) Sector: Medical Devices (존슨앤드존슨 메디칼)
3) Location: Yongsan, Seoul
4) Work Type: Fixed Term
[Summary]
Responsible for finalizing the preparation of Standard Technical Dossier (STED) for initial registrations, product changes, re-registrations and renewals to support Medical Devices products from multiple business units in APAC countries. Assists with preparing necessary information for regulatory submission and prepares general local documentation, forms, and transactions required for final submission in countries as assigned.
[Responsibilities]
1) Compiles information and documentation for routine submissions to APAC local countries regulatory bodies for multiple business units.
2) Ensures collection of all related documentation as required to receive agency approvals or in response to agency requests.
3) Provides basic information to various departments regarding submission requirements and standards to facilitate efficient processing by agencies.
4) Organizes and prioritizes submissions that need review to ensure they meet paper and electronic regulatory submission standards, policies and operating procedure requirements.
5) Organizes and prioritizes regulatory submissions to be reviewed for compliance with submission standards.
6) Ensures compliance with regulatory agency regulations and interpretations.
7) Prepares responses to regulatory agencies' questions and other correspondence as requested.
8) Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
9) Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
10) Provides solutions to a variety of problems of moderate scope and complexity.
[Requirements]
- University/Bachelors degree or equivalent is required. Degree within a technical related discipline is preferred.
- Min 2 years of related experience in Medical Devices is highly preferred
- Excellent communication skills (verbal and written) in English
[JD 확인 및 지원 방법]
www.careers.jnj.com -> Requisition number 1805676575W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”
[제출 서류]
영문 자유 양식의 이력서/자기소개서
[서류 마감일]
채용시 마감
[유의사항]
- 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비 하시기 바랍니다.
- 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연 될 수 있습니다.
- 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다. www.careers.jnj.com