Project Coordinator

Maple Grove, MN - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Project Coordinator
Location (On-site Remote or Hybrid): Maple Grove MN (onsite)
Contract Duration: Contract until 10/30/2026
Working hours: 8:00 AM - 5:00 PM
Total hours: 40

Job Summary

The Project Coordinator will support the Global Regulatory Services team by managing tracking reporting and administrative activities related to EU MDR and international regulatory submissions.
This role is highly administrative and system-focused requiring strong attention to detail and coordination with various teams across different divisions.

This project coordinator will work across all medical device businesses to track status and support the execution of the EU MDR submission/approvals
as well as the international submissions/approvals resulting from EU MDR approval.
(EU MDR approval refers to a medical device meeting the requirements of the European Union Medical Device Regulation so it can be legally marketed and used in the EU).
This position will not be involved in the actual submittal process.
They will be tracking the different teams submissions and tracking approvals
providing a link between the different MD teams and the Global Regulatory Team.

Required Skills & Competencies
Top Skills We Are Looking for in a Candidate:

Excellent communication and coordination skills with the ability to effectively collaborate across multiple teams and stakeholders.
Strong attention to detail and solid administrative skills including the ability to document track update and report information accurately across different teams.
Background or experience in Quality Regulatory or Biomedical fields is preferred.
Previous experience with medical devices is a plus but not required.

Key Responsibilities
Located within the Global Regulatory Services team the project coordinator will be responsible for:

Tracking all the needed submissions and approvals for EU MDR including international
Maintaining updated status to global submissions
Creating metrics monthly to measure/report on status
Establishing relationships with both international regulatory affiliates and business unit affiliates to support the flow of information and project deliverables
Performing record system query updates accuracy and reporting
Providing regular status communications to track and ensure accurate records and on-time submissions
Training international affiliates on proper system recording

Education:

Bachelors degree (BA/BS) required

Job Title: Project Coordinator Location (On-site Remote or Hybrid): Maple Grove MN (onsite) Contract Duration: Contract until 10/30/2026 Working hours: 8:00 AM - 5:00 PM Total hours: 40 Job Summary The Project Coordinator will support the Global Regulatory Services team by managing tracking ...