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: Regulatory Affairs Specialist
2. 계열사: 존슨앤드존슨 서지컬비전 (Surgical Vision)
3. 근무지: 서울시 용산구

4. 근무 형태: Fixed Term

[Responsibilities]

1. Coordinates, compiles, and submits new medical device applications/medical device modifications to the regulatory authorities.

2. Ensures compliance with regulatory authority regulations and interpretations.

3. Gathers and assembles information necessary for submissions and responses to regulatory authorities’ questions.

4. Develops timelines for submissions and maintains reporting schedule under the direction of senior regulatory affairs staff.

5. Provides solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables.

6. Provides regulatory input and assessments to global RA for developing new products and variations in existing products.

7. Conducts and maintains the copy review process for promotional materials and provide consultation to the relevant functions in accordance with regulations and relevant guidelines.

8. Monitors regulatory environment changes and registration status to local, regional, and global stakeholders.

[Requirements]

- 3+ years related experience in Medical Device Industry

- University degree or equivalent, degree in Science/Biomedical Engineering/Pharmaceutical preferred

- Interpersonal skills: Able to work cooperatively and consultatively.

- Communication: Able to communicate with internal and external customers in English & Korean

- Strong leadership, Excellent team player

[지원 방법]
www.careers.jnj.com 접속 -> Position Number 2306135157W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행

[제출 서류]

국&영문 자유 양식의 이력서/자기소개서

[서류 마감일]
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