Advantage Technical · 6 days ago
Regulatory Affairs Specialist II
Fort Worth, TX
Contract
Onsite
Mid Level
$40/hr - $47/hr
3+ years expAdvantage Technical is seeking a Regulatory Affairs Specialist II to support the EU's In Vitro Diagnostic Regulation transition activities. The role involves preparing technical files, updating labeling to comply with IVDR requirements, and participating in cross-functional projects to ensure compliance and track progress.
Staffing & Recruiting
Hiring Manager
Daniel Heidrick
Responsibilities
Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all company 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
Required
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
Knowledge of FDA, and CE marking requirements for IVD products is a plus
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 Regulatory Affairs
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase