[Medical Devices] Sr. Regulatory Affairs Specialist

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Job Description

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.


계열사존슨앤드존슨메디칼 (Medical Devices)

포지션: Sr. Regulatory Affairs Specialist

근무지서울시 용산구

근무형태정규직 (Regular)



1. Takes charge in products from certain franchises.

2. Prepares and submit required regulatory applications for new products and maintenance of existing products with limited supervision.

3. Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters with limited supervision.

4. Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.

5. Follows up of mandatory requirements for registration: local certificates, importation of samples and local testing, etc. with limited supervision.

6.  Monitors and submit regulatory applications for changes of approved products with limited supervision. 

7. Researches and consolidate regulatory requirements and communicate their information with supervisor and manager. 

8. Supports the RA team in projects.

9. Supports in the development of best practices for Regulatory Affairs processes.

10. Provides training and limited supervision of contract resources, as needed. 

11. Conforms regulatory compliance.

12. Has a deep product knowledge of the franchise with responsibility.



1. A minimum Bachelor’s degree is required. 

2. Min. 3 years of progressive experience in Regulatory Affairs.

3. Knowledge of regulatory environment and relative law and regulations.

4. Understanding of regulatory requirements.

5. The incumbent must have the ability to work effectively with limited supervision and process requests/work within required timeframes.


[지원 방법] 접속 -> Position Number 2005802649W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행

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