Regulatory Operations Specialist

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

May 22, 2025 - 08:10

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