Job Description

Regulatory Affairs Specialist – IVDR Transition

Contract: 1 year

Hybrid

Pay Range: $45–$50/hr

Role Overview

Join our client in supporting the transition to the European Union’s In Vitro Diagnostic Regulation (IVDR) , impacting products currently CE Marked under the IVD Directive. In this role, you will contribute to regulatory compliance by revising technical files, updating labeling, coordinating regional notifications, and assisting with related IVDR transition activities.

Key Responsibilities

Technical File Management

• Revise assigned technical files using the latest templates, ensuring each file clearly presents product characteristics, expected performance, and supporting conformity evidence.
• Compile and incorporate the latest technical reports, validations, test data, and other required documentation into the technical files.
• Complete all technical file updates within defined timelines and report progress to the project manager.
• Actively participate in weekly project meetings to resolve issues and maintain alignment across teams.

Labeling Compliance

• Support the IVDR labeling conversion project through cross-functional collaboration and weekly team meetings.
• Maintain and update the labeling conversion tracking log based on manufacturing schedules, product fill dates, lot numbers, and change request records.
• Revise labeling specifications as required to meet IVDR requirements.

Product Updates & Notifications

• Assist with product de-registration (un-CE Marking) and track associated labeling updates until changes are finalized.
• Update the technical file tracking log and monitor RA Regional notifications related to labeling changes.
• Notify the RA SAP restriction coordinator when product lots must be restricted to prevent distribution in specific regions.

Additional Support

• Provide administrative and tracking support for ongoing regulatory activities.
• Ensure all documentation and communications comply with internal policies and regulatory standards.

Qualifications

• Bachelor’s degree in Biochemistry, Biology, Medical Technology, or related field.
• 3–5 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD industry.
• Knowledge of FDA regulations and CE Marking requirements for IVD products (IVDR experience preferred).
• Strong ability to work both independently and collaboratively in a cross-functional environment.
• Excellent communication, negotiation, and persuasion skills.
• Strong analytical, problem-solving, and critical thinking skills; proficiency with computer systems and regulatory documentation tools.
• Thorough understanding of regulatory policies, practices, and procedures.

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