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Advantage Technical · 2 days ago

Regulatory Affairs Specialist

Fort Worth, TX

Contract

Hybrid

Mid Level

$45/hr - $50/hr

3+ years exp

Advantage Technical is seeking a Regulatory Affairs Specialist II to join their team, focusing on the transition to the EU’s In Vitro Diagnostic Regulation (IVDR) for CE-marked IVD products. This role involves ensuring regulatory compliance through technical documentation revisions, labeling updates, and coordinating regional notifications.

Staffing & Recruiting

Growth Opportunities

Hiring Manager

Bill Sunderland

Responsibilities

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

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

Assist in un-CE marking selected products

Track progress until final labeling reflects required changes per specification documents

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

Qualification

Regulatory AffairsIVD industry experienceFDA requirementsCE marking requirementsTechnical documentationAnalytical thinkingProblem solvingCommunication skills