REGULATORY AFFAIRS SPECIALIST

Company: Tucker Parker Smith Group (TPS Group)
Location: Irvine
Posted on: November 1, 2024

Job Description:

Regulatory Affairs Specialist II Location: Irvine, CA (Hybrid 3 days on site)12 month AssignmentPay Rate: $45-$49/hr.

On behalf of our client a medical device client, we are seeking a Regulatory Affair's specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact the company's products currently CE Marked under the IVD Directive.
Job Responsibilities:

• 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.
• 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.
  Education and Experience:
  • Bachelor's degree in biochemistry, biology, medical technology or related fields and 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
  • Thorough knowledge of policies, practices and procedures related to RA.
    Please submit a copy of your resume in Word or PDF format to be considered.

Keywords: Tucker Parker Smith Group (TPS Group), Palmdale , REGULATORY AFFAIRS SPECIALIST, Other , Irvine, California