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IVDR Regulatory Affairs Coordinator

2 months ago

Fort Worth, Texas, United States TCWGlobal Full time
Regulatory Affairs Specialist (R&D/QA)

Location: Remote with On-Site Requirements

Compensation: $43-$45/hr (Weekly pay + Benefits)

Contract Duration: 1 Year (Potential for Extension or Permanent Position)

Work Schedule: Full-time, Monday to Friday, 8 AM - 5 PM

TCWGlobal is seeking a dedicated Regulatory Affairs Specialist to enhance our team. Our organization is at the forefront of innovation, creating advanced instruments and reagents for life science research and healthcare sectors globally. We are committed to improving health outcomes and are looking for a professional to support the transition to the EU's In Vitro Diagnostic Regulation (IVDR) for our CE Marked products.

Key Responsibilities:
  • Provide regulatory guidance for products transitioning from IVDD to IVDR CE Marking.
  • Collaborate with various departments, including Quality Assurance, Research & Development, and Marketing, to gather and coordinate necessary information and documentation for IVDR-compliant technical files.
  • Maintain and update the IVDR Labeling Conversion Log, ensuring all documentation is prepared and processed in a timely manner to align with manufacturing schedules.
  • Assist in generating Change Requests for product labeling in accordance with the Labeling Conversion Plan.
  • Facilitate communication and assist in the notification process to all International Regional Regulatory Affairs teams, including logging responses and tracking activities to completion.
  • Perform additional IVDR or regulatory-related tasks as assigned.
Qualifications:
  • Bachelor's degree or equivalent in Biology, Chemistry, Medical Technology, or a related discipline.
  • 2-8 years of experience in Regulatory Affairs or Quality Assurance, preferably within the IVDR sector.
  • Proficient in labeling processes and change requests, ensuring timely documentation for manufacturing.
  • Experience in the IVDR industry is highly desirable.
  • Strong computer skills, including experience with ERP systems.
  • Ability to conduct basic statistical analyses.
  • Excellent written and verbal communication skills.
  • Strong organizational and documentation capabilities.

TCWGlobal is an equal opportunity employer, committed to diversity and inclusion in the workplace.