한국스트라이커(Stryker) 신입, 경력 /정규직 채용
회사소개: Stryker는 미국 미시건주에 본사를 둔 외국계 기업으로 정형외과 임플란트, 수술용 의료기기와 신경혈관 의료기기 및 각종 Medical device를 제조 및 유통하고 있습니다. 100개 이상의 국가에서 Stryker 제품이 의사, 병원 및 기타 의료 시설에 판매되고 있습니다.
해외 규모: 매출 180억 달러, 직원 수 46,000명
국내 규모: 매출 1,532억 원, 직원 수 156명, GPTW Institute ‘일하기 좋은 기업’ 5년 연속 대상
(참조: https://www.greatplacetowork.co.kr/kr/certification/certified-companies/stryker_2023)
채용 인원: O명
모집 부문: RA Specialist (1년 계약직)
This role is to process MFDS product registrations w/ KGMP certification and post market surveillance of medical device in compliance with Regulatory & Corporate’s requirements.
Essential duties & responsibilities: (detailed description)
ﾷ Review, track, and manage Change Notifications and take necessary action
ﾷ Data management including UDI after product registration at the internal Stryker system
ﾷ Support and execute the compilation of submission dossiers working with design divisions and tracking till registration is complete
ﾷ Processing new and renewal of KGMP certification for MFDS product registration and maintenance
ﾷ Involve SKL’s QMS activities to maintain Stryker Korea’s QMS efficiently, which is complied with MDA(medical device act) observations, ISO 13485 standards, and with Stryker standards. Those can be such as quality documentation, internal audit, training, participation in internal or external audits, etc.
ﾷ Collaborate with business franchise partner, Stryker Design division RAQA, and regulatory agencies and draw out effective communications and resolutions on any issues that may arise on work
ﾷ Participate in various RA/QA projects internally and externally
ﾷ Do every work in compliance with regulatory requirements and Stryker corporate requirements.
Education & special training:
ﾷ BA in science, engineering, medical, law, etc.
ﾷ Better if fluent in English
Qualifications & experience:
ﾷ Open to graduates
ﾷ Min 1 year of RA experience in the healthcare industry preferred
ﾷ Better to have relevant experience of Government officials
Physical & mental requirements:
ﾷ Well-organized and logical thinking
ﾷ Passionate and a great sense of responsibility
ﾷ Committed to punctuality, discipline & detailed
ﾷ Professional communication skills
ﾷ Strategic and planning skills
이력서 접수: https://stryker.wd1.myworkdayjobs.com/StrykerCareers/job/Seoul-Korea/RA-Specialist--1--_R501369
이력서 검토 후 연락 드릴 예정입니다.