존슨앤드존슨 [한국얀센] Associate RA Manager 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 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] - 1~4 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] 국&영문 자유 양식의 이력서/자기소개서
[서류
마감일]
[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.
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