Position Title: Project Coordinator
 Work Location: Maple Grove, MN 55311
Assignment Duration: 5+ Months
Work Schedule: Mon – Friday, Daytime hours (8:00 AM - 5:00 PM)
Work Arrangement: 100% Onsite (may be some flexibility for WFH days in the future)

Position 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.

Background & Context: 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.
Key Responsibilities:

• 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

Qualification & Experience:

• 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.
• Bachelor’s degree (BA/BS) required

 
  
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 42.00/daily.