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Quality Assurance Regulatory Specialist

2 months ago

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

Location: Fort Worth, TX (Local candidates preferred)

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

Contract Duration: 1 year (Strong potential for extension or permanent position)

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

TCWGlobal is seeking a dedicated Regulatory Affairs Specialist to join our innovative team. Our organization is committed to developing cutting-edge instruments and reagents for life science research and healthcare sectors globally. In this role, you will play a crucial part in supporting the transition activities related to the EU's In Vitro Diagnostic Regulation (IVDR) for products currently CE Marked under the IVD Directive.

Key Responsibilities:
  • Provide regulatory guidance for products transitioning from IVDD to IVDR CE Marking.
  • Collaborate with cross-functional teams, including Quality Assurance, Research & Development, and Marketing, to gather and coordinate information and regulatory documentation necessary for assembling IVDR-compliant technical files.
  • Maintain and update the IVDR Labeling Conversion Log, ensuring all documentation is prepared and processed promptly 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 required.
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.
  • Experience with product labeling and change requests, ensuring timely documentation to meet manufacturing requirements.
  • Familiarity with IVDR regulations is highly advantageous.
  • Proficient in computer applications, with experience in ERP systems.
  • Ability to conduct basic statistical analyses.
  • Strong written and verbal communication skills.
  • Excellent documentation and organizational capabilities.
TCWGlobal is an equal opportunity employer, committed to diversity and inclusion in the workplace.