Regulatory Affairs Specialist (Irvine)

Job Title : Regulatory Affairs Specialist II

Location : Hybrid Core onsite days are Tuesday and Thursday; third onsite day is flexible Duration : 1 Year Contract - possible extension

Pay Range : $45$50 / hour

Position Overview

Join our client's Regulatory Affairs team to support the transition to the EUs In Vitro Diagnostic Regulation (IVDR), impacting all CE-marked IVD products. This role plays a critical part in ensuring regulatory compliance by revising technical documentation, updating labeling, and coordinating regional notifications.

Key Responsibilities

• Technical File Management :
• Revise assigned technical files using the latest templates.
• Ensure each file clearly presents product details, performance expectations, and supporting evidence of conformity.
• Incorporate updated technical reports, validations, and test documentation.
• Complete each file within defined timelines and participate in weekly project meetings to report progress and resolve issues.
• Labeling Compliance :
• Support IVDR labeling conversion efforts through cross-functional collaboration.
• Maintain and update the labeling conversion tracking log based on manufacturing schedules, product fill dates, lot numbers, and change request references.
• Revise labeling specifications to meet IVDR requirements.
• Product De-Registration :
• Assist in un-CE marking selected products.
• Track progress until final labeling reflects required changes per specification documents.
• Regulatory Coordination :
• Update the technical file tracking log.
• Notify and track RA Regional updates related to labeling changes.
• Communicate with the RA SAP restriction coordinator to ensure product lot restrictions are properly implemented.

Qualifications