Jobs

Description

Project Coordinator

Maple Grove, MN 55311

100 percent onsite (may be some flexibility for WFH days in the future)

Days/Hours: Mon – Friday Daytime hours (08:00 AM – 05:00 PM)

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 client 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:

• Bachelor’s degree (BA/BS) required