Job Description

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

• Bachelors degree in Biochemistry, Biology, Medical Technology, or a related field.
• 35 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD industry.
• Familiarity with FDA and CE marking requirements for IVD products is preferred.
• Strong ability to work independently and collaboratively across teams.
• Excellent communication skills, including negotiation and persuasion.
• Proficient in analytical thinking, problem solving, and computer-based documentation.
• Deep understanding of regulatory policies, procedures, and best practices.

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