Johnson & Johnson Careers
[Medical Devices] Regulatory Affairs Specialist
Requisition ID: 1805699444W
& 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: Regulatory Affairs Specialist
2. 계열사: 존슨앤드존슨 메디칼 (Medical Devices)
3. 근무지: 서울시 용산구
4. 근무 기간: 1년 6개월 (Fixed Term)
Coordinates, compiles, and submits new product applications, abbreviated new product applications and investigational new product applications 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 for new product application and investigational new product applications. Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of limited scope and complexity. Conducts searches of existing files for requested information. Maintains and archives all regulatory documentation.
1) Takes charge in products from certain franchises.
2) Ensures collection of all related documentation as required to receive agency approvals or in response to agency requests.
3) Organizes and prioritizes submissions that need review to ensure they meet paper and electronic regulatory submission standards, policies and operating procedure requirements.
4) Organizes and prioritizes regulatory submissions to be reviewed for compliance with submission standards.
5) Ensures compliance with regulatory agency regulations and interpretations.
6) Prepares responses to regulatory agencies' questions and other correspondence as requested.
7) Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
8) Supports the RA team in projects.
9) Provides solutions to a variety of problems of moderate scope and complexity.
10) Conforms regulatory compliance.
1) A minimum Bachelor’s degree is required.
2) Min. 2 years of progressive experience in Regulatory Affairs.
3) Understanding of regulatory requirements.
4) Ability to work both independently and in a team environment.
5) Ability to problem solve, recognize and find solutions for gaps in processes
6) Demonstrates a basic scientific and technical understanding of medical devices and life-cycle management with a basic knowledge and understanding of the regulatory environment and relative raw and regulations.
7) Understands business environment and business strategies, and develops effective and results-oriented regulatory strategic plans that are in line with business objectives
8) Utilizes strategic thinking and intellectual curiosity to generate effective ideas or solutions
9) Makes decisions and prioritizes with guidance and helps from others to make timely and effective decisions and appropriate prioritization.
10) 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).
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Johnson & Johnson Medical Korea (Ltd.) (7225)