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[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)

 

[Responsibilities]

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.

 

[Requirements]

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]
www.careers.jnj.com 접속 -> Position Number 2005802649W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행


[제출 서류]

영문 자유 양식의 이력서/자기소개서

 

[서류 마감일] 
채용시 마감

 

[For more Johnson & Johnson]

- J&J Korea Facebook: https://www.facebook.com/JNJCareersKorea/

- J&J Korea Linkedin: https://www.linkedin.com/in/country-recruiter-talent-acquisition-296167147/

“좋아요” & “팔로우” - 존슨앤드존슨 오픈 포지션 및 다양한 소식들을 페이스북, 링크드인 페이지 통해 만나 보시기 바랍니다.  


[유의사항] 
- 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비하시기 바랍니다.
- 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연될 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
2005802649W