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[Medical Devices] Regulatory Affairs Manager

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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.

 

- 계열사: 존슨앤드존슨메디칼 (Medical Devices)

- 포지션: Regulatory Affairs Manager

- 근무지: 서울시 용산구

- 근무형태: 정규직 (Regular)

 

[Summary]

Johnson & Johnson Medical Korea is recruiting for an RA Manager, located in Seoul.

Provides support to the Regulatory Affairs for Medical Devices, and has the opportunity to be a team lead responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance. Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters. Consults with management personal to establish strategies and prepare appropriate regulatory filings for the regulatory activities. Generally, has responsibility for projects of medium and large scope, such as accountability for regional/global/multi-functional projects.

 

[Responsibilities]

1. Leads and executes regulatory activities to meet commercial/regulatory requirements.

2. Developes NPI strategies with the goal of expedited approval, resolving regulatory issues and provides technical guideline to team during the course of submission preparation and interaction with regulatory agencies.

3. Assists in establishing project priorities, allocating resources and workload to execute regulatory activities.

4. Takes regulatory leadership role offered projects in local/region/global.

5. Specifically develops strong working relationships with affiliate regulatory contacts and the business.

6. Represents Regulatory Affairs on cross-functional teams in the local business to provide scientific and regulatory support as needed to business partners.

7. Actively monitoring the regulatory environment, interprets changes, analyzes impact, and influences industry bodies to ensure that industry position is appropriately represented.

8. Supports direct reports for continuous development in regulatory knowledge and leadership area.

 

[Requirements]

1) Bachelor’s degree preferably in a scientific, technical discipline or project management.

2) 8+ years Regulatory Affairs or related field, Medical Device experience

3) Experienced in dealing product registration, registration maintenance and KGMP in medical device product categories

4) Experienced in developing team and leading team project

5) Excellent communication and strong interpersonal skills

6) Ability to collaborate with cross-functional partners/teams

7) Strong project management skills

8) Well defined problem solving

9) Strong sensitivity for dynamic and multi-cultural environments

10) Experienced in driving industry projects as a lead

11) Experience with international regulations

12) Proven analytical abilities

13) Proficient in English both oral or written

 

[지원 방법]
www.careers.jnj.com 접속 -> Position Number 1905789408W 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/

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[유의사항] 
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www.careers.jnj.com



Qualifications
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Primary Location
South Korea-Seoul-Yongsan-gu-
Organization
Johnson & Johnson Medical Korea (Ltd.) (7225)
Job Function
Regulatory Affairs
Requisition ID
1905789408W