Regulatory Operations Specialist

Job Summary

A company is looking for a Regulatory Operations Specialist.

Key Responsibilities

• Act as the primary point of contact for registration and listing, ensuring effective communication with internal stakeholders
• Collaborate with Owner/Operators and Official Correspondents to manage FURLS accounts and ensure compliance with FDA regulations
• Oversee annual registration processes and maintain documentation for compliance and accuracy

Required Qualifications

• Bachelor's degree with at least 2 years of relevant experience
• Strong understanding of FDA regulations related to medical device registration and listing
• Experience with the Device Registration and Listing Module (DRLM) in FURLS is a plus
• Proven ability to collaborate effectively with upper leadership
• Advanced proficiency in Microsoft Office and related software