行业：Sciences
职位：Science & Technology
部门：
人数：若干
性质：Full Time
性别：Male
婚姻：No marital status restrictions
学历： Bachelor's Degree
经验：不限
年龄：18岁以上
待遇：面议
Job description:
A Day in the Life
Support the activities of Shared Service Center department in Regulatory Affairs Operations across Asia Pacific RegionResponsible for the centralization of activities associated with standard regulatory workSupport country registration submission preparation across Asia Pacific RegionKey Accountabilities:Support registration projects across Asia Pacific regionSupport the product registration process including Insight request, review & compilation of the registration in coordination of the Project Lead & In-country Regulatory Affairs.Support management of regulatory tools and database across Asia Pacific region e.g. publishing, eIFU maintenance in Medtronic siteMaintain internal regulatory systems, database & processes, relating to regulatory & quality such as Insight, SAP, GTSLiaise with global regulatory affairs on requested documentsTimely reporting to various stakeholders on the status of ongoing projectsOther duties assigned by the Asia Pacific QRA - Shared Services Center ManagerWhat we offer:
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Required profile:
Qualifications:
Bachelor's degree in science of health-related disciplineMinimum 5-year regulatory experience in medical deviceStrong background in STED, CSDTBackground in regulatory tools and databaseAttributes:Strong oral and written communication skillsEffective communication, organizational, and interpersonal skillsPossess accuracy and strong attention to detailsGood problem-solving skills -Able to solve issues quickly and effectivelyAbility to work independently and to effectively prioritize tasksAbility to support multiple projectsEager to learn new things & ready to take up new challenge constantlyExperience working in an environment with global objectives.'Can do' attitudeAdaptable to changesExperience and Knowledge:Performing Administrative Activities - Performing day-to-day administrative tasks such as maintaining information files and processing paperworkComputer literacy including sound knowledge of the MS Office Suite of software.Organizing, Planning, and Prioritizing Work - Developing specific goals and plans to prioritize, organize, and accomplish your workRequired profile:
Qualifications:
Bachelor's degree in science of health-related disciplineMinimum 5-year regulatory experience in medical deviceStrong background in STED, CSDTBackground in regulatory tools and databaseAttributes:Strong oral and written communication skillsEffective communication, organizational, and interpersonal skillsPossess accuracy and strong attention to detailsGood problem-solving skills -Able to solve issues quickly and effectivelyAbility to work independently and to effectively prioritize tasksAbility to support multiple projectsEager to learn new things & ready to take up new challenge constantlyExperience working in an environment with global objectives.'Can do' attitudeAdaptable to changesExperience and Knowledge:Performing Administrative Activities - Performing day-to-day administrative tasks such as maintaining information files and processing paperworkComputer literacy including sound knowledge of the MS Office Suite of software.Organizing, Planning, and Prioritizing Work - Developing specific goals and plans to prioritize, organize, and accomplish your work