Regulatory Affairs Project Coordinator III

Local Jobs Medtronic
  • United States, Boulder, CO 80301 View on Map
  • Post Date : September 16, 2020
  • Apply Before : October 16, 2020
  • Share:

Job Description

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.

As Project Coordinator III you will support project and programs for the Regulatory Affairs group.

A Day in the Life

Responsibilities 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 Review
  • Maintain CFG and FSC inventory
  • Maintain ISO/EC/DOCs on SharePoint site
  • Notary for International Documents
  • Assist with regulatory submissions as needed
  • Receipt, logging and Shipping of International documents
  • Responsible for management of documents for legalization
  • Responsible for updating metrics for the department
  • Monitor and manage InSight database and SmartSheet task tracker
  • Prepare agenda and minute for region calls

Responsibilities 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 Requirements

  • 4+ years of experience providing project or program support to a functional group or business process
  • High School diploma or equivalent

Nice to Have

  • Associates or Bachelor’s Degree
  • Experience in a regulated industry such as drugs or medical devices


About Medtronic

Together, 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)

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Regulatory Affairs Project Coordinator III

Local Jobs Medtronic
  • United States, Boulder, CO 80301 View on Map
  • Post Date : August 27, 2020
  • Apply Before : September 26, 2020
  • Share:

Job Description

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.

As Project Coordinator III you will support project and programs for the Regulatory Affairs group.

A Day in the Life

Responsibilities 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 Review
  • Maintain CFG and FSC inventory
  • Maintain ISO/EC/DOCs on SharePoint site
  • Notary for International Documents
  • Assist with regulatory submissions as needed
  • Receipt, logging and Shipping of International documents
  • Responsible for management of documents for legalization
  • Responsible for updating metrics for the department
  • Monitor and manage InSight database and SmartSheet task tracker
  • Prepare agenda and minute for region calls

Responsibilities 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 Requirements

  • 4+ years of experience providing project or program support to a functional group or business process
  • High School diploma or equivalent

Nice to Have

  • Associates or Bachelor’s Degree
  • Experience in a regulated industry such as drugs or medical devices


About Medtronic

Together, 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)

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