Regulatory Affairs Coordinator

Job Summary

A company is looking for a Coordinator 3, Regulatory Affairs (Remote).

Key Responsibilities

• Support US and EU regulatory submissions and track timelines and milestones
• Assess regulatory impact and develop regulatory strategy
• Provide guidance on registration requirements and approve change requests

Required Qualifications

• Bachelor's Degree or equivalent in a scientific discipline (e.g., Biology, Microbiology, Chemistry)
• 5-7 years of relevant experience required
• Proven expertise in Microsoft Office Suite including Word, PowerPoint, and Excel
• Solid knowledge of global regulations for medical devices, Class II and/or Class III
• Understanding of global regulatory requirements for new products or product changes