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Medtronic: Regulatory Affairs Project Coordinator Iii


This is a Full-time position in Boulder, CO posted September 19, 2020.

Careers that Change Lives Respiratory, Gastrointestinal & Informatics (RGI) offers technologies to help with early detection and treatment of gastrointestinal diseases and cancers and focuses on reducing respiratory complications through interventional solutions and patient monitoring.

AsProject Coordinator IIIyou will support project and programs for the Regulatory Affairs group.A Day in the LifeResponsibilities may include the following and other duties may be assigned.Gathers and compiles information for reports.Records Coordinator – maintain onsite RA files, Iron Mtn files and Annual Records ReviewMaintain CFG and FSC inventoryMaintain ISO/EC/DOCs on SharePoint siteNotary for International DocumentsAssist with regulatory submissions as neededReceipt, logging and Shipping of International documentsResponsible for management of documents for legalizationResponsible for updating metrics for the departmentMonitor and manage InSight database and SmartSheet task trackerPrepare agenda and minute for region callsResponsibilities may also include the following and other duties may be assigned.Provides project or program support to a functional group or business process.Monitors program/project/system status, budgets and timetables.Applies knowledge of and experience in company operations to assist in the development, implementation and administration of program/system guidelines and procedures.Gathers and compiles information for reports.Provides technical support, which may include program/system training, program/system documentation, data extraction, data review, tracking and coding.Must Have: Minimum Requirements4+ years of experience providing project or program support to a functional group or business processHigh School diploma or equivalentNice to HaveAssociates or Bachelor’s DegreeExperience in a regulated industry such as drugs or medical devicesAbout MedtronicTogether, we can change healthcare worldwide.

At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.

We challenge ourselves and each other to make tomorrow better than yesterday.

It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations but we will only succeed with the right people on our team.

Let’s work together to address universal healthcare needs and improve patients’ lives.

Help us shape the future.

Physical Job Requirements The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile.

The employee is also required to interact with a computer, and communicate with peers and co-workers.

Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

(ADA-United States of America)