Job description:
A Day in the Life
Support the activities of Shared Service Center department in Regulatory Affairs Operations across Asia Pacific Regio
nResponsible for the centralization of activities associated with standard regulatory workSupport country registration submission preparation across Asia Pacific Region
Key Accountabilities:Support registration projects across Asia Pacific regio
nSupport 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 databa
se across Asia Pacific region e.g. publishing, eIFU maintenance in Medtro
nic siteMaintain internal regulatory systems, databa
se & processes, relating to regulatory & quality such as Insight, SAP, GTSLiaise with global regulatory affairs on requested docu
mentsTimely reporting to various stakeholders on the status of o
ngoing projectsOther duties assigned by the Asia Pacific QRA - Shared Services Center Manager
What we offer:
.
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 databa
se
Attributes:Strong oral and written communication skillsEffective communication, organizational, and interperso
nal 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 co
nstantlyExperience working in an enviro
nment with global objectives.'Can do' attitudeAdaptable to changes
Experience 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 databa
se
Attributes:Strong oral and written communication skillsEffective communication, organizational, and interperso
nal 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 co
nstantlyExperience working in an enviro
nment with global objectives.'Can do' attitudeAdaptable to changes
Experience 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