[Surgical Vision] RA Specialist - 2406179212W

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

1. 포지션: RA Specialist

2. 계열사: 존슨앤드존슨 서지컬비전 (Surgical Vision)

3. 근무지: 서울시 용산구

4. 근무 형태: Fixed Term(1 year)

[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]

• 14 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 2406179212W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행

[제출 서류]

국&영문 자유 양식의 이력서/자기소개서

[서류 마감일]

채용시 마감

[유의사항]

• 국가 보훈 대상자 및 장애인은 관련 서류 제출 시 관계 법령에 의거하여 우대합니다.

• 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연될 수 있습니다.

• 입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후라도 채용이 취소될 수 있으며 향후 채용이 제한됩니다.

• 제출된 서류는 반환되지 않으며, 별도 요청 시 삭제합니다.

Qualifications

See above.

Primary Location Asia Pacific-South Korea-Seoul-Yongsan-gu

Organization AMO Asia Limited (Korea Branch) (8248)

Job Function Regulatory Affairs

Req ID: 2406179212W