Data Management Specialist

2 weeks ago

Los Angeles, California, United States Tucker Parker Smith Group (TPS Group) Full time $62,400 - $83,200 per year

Data Management Specialist – IVDR (EUDAMED)

Location:
California (Remote) - Pacific Time, 8:00 AM – 5:00 PM

Duration:
6 month assignment (potential to extend / convert)

Pay Range:
$30 – $40/hour

About the Role

On behalf of our client, a leading manufacturer of life science research and clinical diagnostic products, we are seeking a
Data Management Specialist
to join the Regulatory Affairs and Quality teams in support of the EU In Vitro Diagnostic Regulation (IVDR).

This role focuses on the collection, organization, and entry of regulatory data related to medical device registrations and associated attributes into the company's Product Data Management (PDM) system. The specialist will also assist with system validation testing and the development of Standard Operating Procedures (SOPs) to ensure long-term data accuracy and compliance.

Key Responsibilities

  • Gather, consolidate, and verify regulatory data related to IVDR device registrations from internal and external sources.
  • Enter, maintain, and validate data in the Product Data Management system, ensuring accuracy, completeness, and compliance with internal standards.
  • Develop and document Standard Operating Procedures (SOPs) and work instructions to support data governance and integrity.
  • Collaborate with Regulatory Affairs, Quality, R&D, and Supply Chain teams to align and maintain traceable data across functions.
  • Support system validation testing and continuous improvement initiatives related to data quality and process efficiency.
  • Identify and escalate data inconsistencies or process gaps to relevant stakeholders.

Qualifications

  • Bachelor's degree (or equivalent) in Life Sciences, Quality Management, Regulatory Affairs, or a related field.
  • 1–2 years of experience in the medical device or in vitro diagnostics (IVD) industry is highly preferred.
  • Proficiency in Microsoft Word and Excel.

Please submit your resume in Word or PDF format to be considered.

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