Johnson & Johnson Careers
[Medical Devices] Regulatory Affairs Specialist
Requisition ID: 1905728609W
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 Specialist
- 근무지: 서울시 용산구
- 근무형태: 계약직(Fixed term) 1년
Coordinates, compiles, and submits product and KGMP applications to the regulatory agencies for the relevant project.
Ensures compliance with regulatory agency regulations and interpretations.
Prepares responses to regulatory agencies questions and other correspondence.
Provides 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) Initiate, track and facilitate products registrations and maintenances from certain project and achieve on-time approvals.
2) Ensures collection of all related documentation as required to receive agency approvals or in response to agency requests.
3) Organizes and prioritizes regulatory submissions to be reviewed for compliance with submission standards, regulations and interpretations.
4) Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.
5) Maintain regulatory compliance of registered products.
6) Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides for assigned projects.
7) Supports the RA team in projects.
8) Provides solutions to a variety of problems of moderate scope and complexity.
1) A minimum Bachelor’s degree is required.
2) Min. 1-2 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) Utilizes strategic thinking and intellectual curiosity to generate effective ideas or solutions
8) 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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