Regulatory Affairs Analyst

Overview

Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X‑ray products. The role is a key player in a cross‑functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality, and Customers.

Responsibilities

• Keep abreast of medical device regulatory procedures, safety standards and changes in global regulations.
• Maintain strong working knowledge of FDA regulations and those of UK, EU, ISO13485, Brazil, Australia, China, Japan, Canada, and other regions.
• Compile all materials required for submissions, license renewal and annual registrations to FDA, Health Canada, China NMPA, and other international authorities.
• Support global product registrations, including compilation and maintenance of regulatory dossiers, technical documentation, and country‑specific submission materials.
• Perform device classification assessments in accordance with regulat...