Regulatory Affairs System Specialist

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 Manager

What 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 work

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 work

Bold thinking. Bolder actions. We are Medtronic. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary