Regulatory Affairs Specialist jobs in United States
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Radiant Systems Inc ยท 1 day ago

Regulatory Affairs Specialist

positionFort Worth, TX
timeContract
remoteHybrid
seniorityMid Level
money$45/hr - $50/hr
date3+ years exp

Radiant Systems Inc is focused on supporting the transition to the EU's In Vitro Diagnostic Regulation (IVDR) for their CE Marked products. The Regulatory Affairs Specialist will be responsible for revising technical files, updating labeling to meet IVDR requirements, and tracking regional notifications while ensuring compliance with project timelines.

CRMInformation TechnologySoftware

Responsibilities

Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Client's products currently CE Marked under the IVD Directive
Activities include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional notifications, and other related activities
Support the IVDR project by revising the assigned technical files. Each technical file must be generated using the latest technical file template and it must clearly present the product, its characteristics and its expected performance to easily and fully understand the evidence of conformity. Each technical file must include the latest version of the required technical reports, validations, test reports and other documents listed in the technical file table of contents which are an integral part of the technical file. Each assigned technical file must be completed within a pre-defined timeline. Must attend multiple weekly meetings which are intended to help address issues or questions regarding the technical files and keep the project manager informed on the progress of the work
Support the IVDR labeling conversion project which requires cross-functional participation and weekly group meetings to follow the conversion plan. Update the labeling conversion tracking log based on the monthly manufacturing schedule, the product fill dates, the associated product lot numbers and change requests numbers. As needed, update labeling specifications to meet the IVDR requirements
Support the tasks to un-CE Mark selected products and track the work until the final labeling reflects the desired changes based on the labeling specification document
Other miscellaneous activities will include updating the technical file tracking log, notifying and tracking RA Regional notifications of labeling changes, and notifying the RA SAP restriction coordinator when specific product lots need to be restricted to prevent distribution of the product in specific areas of the world

Qualification

Regulatory Affairs (RA)IVD industry experienceFDA knowledgeCE marking knowledgeAnalytical skillsComputer skillsCommunication skillsProblem solving skillsCritical thinking skillsTeamwork

Required

Requires a Bachelor's degree in biochemistry, biology, medical technology or related fields
3+ years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry
Able to work independently and with others
Communication skills, including negotiation and persuasion
Analytical, problem solving, computer, and critical thinking skills
Thorough knowledge of policies, practices and procedures related to RA

Preferred

Knowledge of FDA, and CE marking requirements for IVD products is a plus

Company

Radiant Systems Inc

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Radiant Systems, Inc. is a certified Minority Business Enterprise, a Global Consulting company founded in 1995.
dateFounded in 1995
location
New Jersey, Saint Patrick, TTO
people-size501-1000 employees
web-link
http://radiants.com

Funding

Current Stage
Late Stage

Leadership Team

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Rayn Kamesh
Head of Sales/Director, Strategic Partnership - MSP/VMS Accounts
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