Johnson & Johnson Careers

[Medical Devices] Sr. RA Specialist

Yongsan-gu, Seoul
Regulatory Affairs


Job Description

Requisition ID: 1805650670W

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. 포지션: Sr. RA Specialist 

2. 계열사: 존슨앤드존슨 메디칼 (Medical Devices)

3. 근무지: 서울시 용산구

 


[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 South Korea. 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 South Korea 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/Bachelor’s degree or equivalent is required. Degree within a technical related discipline is preferred.

- Min 4 years of related experience is required.

- Ability to work both independently and in a team environment.

- Ability to problem solve, recognize and find solutions for gaps in processes

- A combination of background, education and experience can be considered.

- Excellent communication skills (verbal and written) in English.


[JD 확인 및 지원 방법]

www.careers.jnj.com -> Requisition number 1805650670W 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


Qualifications
-
Primary Location
South Korea-Seoul-Yongsan-gu
Organization
Johnson & Johnson Medical Korea (Ltd.) (7225)
Job Function
Regulatory Affairs
Requisition ID
1805650670W