[MedTech] RA Specialist, Special Project

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) [Responsibilities] 1. Takes charge in products for assigned projects. 2. Prepares and submits required regulatory applications for new products for replacement, change of manufacturing process 3. Monitors and submits regulatory applications for changes of approved products 4. Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters 5. Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested. 6. Follows up of mandatory requirements for registration: local certificates, importation of samples and local testing, etc. 7. Researches and consolidate regulatory requirements and communicate their information with supervisor and manager. 8. Supports the RA team in projects. 9. Supports in the development of best practices for Regulatory Affairs processes. 10. Conforms regulatory compliance. 11. The incumbent must have the ability to work effectively and process requests/work within required timeframes. 12. A team player with a diligent and sincere attitude and mindset 13. Has a strong sense of responsibility on meeting due/target and quality/integrity/accuracy of the output 14. Views new and ambiguous challenges as a learning opportunity [Requirements] Min. 2 years of progressive RA experience in HealthCare industry. Knowledge of regulatory environment, relative law and regulations on Medical Devices. Understanding of regulatory requirements. Good at writing and translation skill in English Less than 10% travel (oversea and domestic) Prefer holding a Regulatory Affairs Certification (RAC) Expert in MS Word, Excel, Power Point and HWP etc. [지원 방법] www.careers.jnj.com 접속 -> Position Number 2206050624W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행 [제출 서류] 영문 자유 양식의 이력서/자기소개서 [서류 마감일] 채용시 마감 [For more Johnson & Johnson] - J&J Korea Facebook: https://www.facebook.com/JNJCareersKorea/ - J&J Linkedin: https://www.linkedin.com/company/johnson-&-johnson/ - J&J Corporate Page: http://www.jobkorea.co.kr/Company/1605233/Info [유의사항] - 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비하시기 바랍니다. - 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연될 수 있습니다. - 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다. www.careers.jnj.com At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. Qualifications - Primary Location South Korea-Seoul-Yongsan-gu- Organization Johnson & Johnson Medical Korea (Ltd.) (7225) Job Function Regulatory Affairs Requisition ID 2206050624W