[MedTech] Regulatory Affairs Specialist

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: RA Specialist

2. 계열사: 존슨앤드존슨 메디칼 (MedTech)

3. 근무지: 서울시 용산구

4. 근무 형태: Regular

[Summary]

Coordinates, compiles, and submits applications of new products or changes to the approved products to the regulatory agencies. Assists with ensuring compliance with regulatory agency regulations and interpretations. Assists with the preparation of responses to regulatory agencies' questions and other correspondence. Assists with organizing and maintaining reporting schedules of new product registration, changes in products, projects, etc. Assists with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope and complexity. Conducts searches of existing files for requested information. Maintains and archives all regulatory documentation.

[Responsibilities]

1. Prepares, submits, and monitors applications of new products(NPI), changes in approved products(License Renewal), and KGMP with a certain degree of supervision.

2. Applies knowledge in regulations and characteristics of products to prepare compliant regulatory strategies and to assess regulatory impact on products as product life-cycle management.

3. Interacts with regulatory agency personnel in order to expedite approval applications and to resolve regulatory matters with a certain degree of 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, local testing, etc. with a certain degree of supervision.

6. Ensures Korean label contents and approves the final Korean label artwork.

7. Researches and consolidates regulatory requirements and actively communicates with the supervisor and the manager.

8. Supports projects in the RA team and the enhancement for Regulatory Affairs processes.    Conforms regulatory compliance.

9. Understands business environment and business strategies and develops effective and results-oriented regulatory strategic plans that are in line with business objectives. Manages specific project steps to meet milestones independently, with some supervision or as a part of the team.

10. Understands the major trends in the healthcare environment, changes in external marketplace, and competitors’ tendency and the influence of social, economic, and political factors on business and regulatory environment.

Leadership Competencies:

1. Utilizes strategic thinking and intellectual curiosity to generate effective ideas or solutions.

2. Makes decisions and prioritizes with guidance and helps from others to make timely and effective decisions and appropriate prioritization.

3. Acts with speed, agility and accountability in the decision making and balances short and long-term decisions and activities. Demonstrates an enterprise-wide mindset.

4. Manages specific project steps to deliver required objectives independently/or with some supervision or as part of a team (for example, managing individual aspects of regulatory submissions).

[Requirements]

• A minimum Bachelor’s degree

• Min. 2 years of experience in Regulatory Affairs

• Understanding in regulatory requirements, laws, standards, and environment

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

• Strong communication and interpersonal skills

• Fluent in both verbal and written English

[지원 방법]
www.careers.jnj.com 접속 -> Position Number 2306101191W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행
 

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[서류 마감일] 
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[For more Johnson & Johnson]

• J&J Careers 유튜브 채널 : https://www.youtube.com/channel/UCZEsWOZwbcjcXHrgYq7sP4Q

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• J&J Linkedin: https://www.linkedin.com/company/johnson-&-johnson/

• J&J Corporate Page: http://www.jobkorea.co.kr/Company/1605233/Info

[유의사항]

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