Johnson & Johnson Careers
[Medical Devices] Sr. Regulatory Affairs Specialist
Requisition ID: 1905724540W
& 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: Sr. Regulatory Affairs Specialist
- 근무지: 서울시 용산구
- 근무형태: 계약직(Fixed term) 1년 (평가 후 연장 가능)
Responsible for finalizing the preparation of Standard Technical Dossier (STED) for initial registrations, product changes, re-registrations and renewals to support Medical Devices products from multiple business units in South Korea. Assists with preparing necessary information for regulatory submission and prepares general local documentation, forms, and transactions required for final submission in countries as assigned.
1) Compiles information and documentation for routine submissions to South Korea regulatory bodies for multiple business units.
2) Ensures collection of all related documentation as required to receive agency approvals or in response to agency requests.
3) Provides basic information to various departments regarding submission requirements and standards to facilitate efficient processing by agencies.
4) Organizes and prioritizes submissions that need review to ensure they meet paper and electronic regulatory submission standards, policies and operating procedure requirements.
5) Organizes and prioritizes regulatory submissions to be reviewed for compliance with submission standards.
6) Ensures compliance with regulatory agency regulations and interpretations.
7) Prepares responses to regulatory agencies' questions and other correspondence as requested.
8) Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
9) Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
10) Provides solutions to a variety of problems of moderate scope and complexity.
- Functional and Technical Competencies
1) Excellent communication skills (verbal and written) in English
2) Presentation skills
3) Strong organizational skills
4) Project management skills
5) Problem solving skills
- EDUCATION & EXPERIENCE REQUIREMENTS:
1) University/Bachelors degree or equivalent is required. Degree within a technical related discipline is preferred.
2) Minimum 4-5 years of related experience is preferred.
3) Ability to work both independently and in a team environment.
4) Ability to problem solve, recognize and find solutions for gaps in processes
5) A combination of background, education and experience can be considered.
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