Data Management Specialist

2 days ago

Los Angeles, California, United States Advantage Technical Full time

Position: Data Management Specialist – IVDR (EUDAMED)

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

Duration:
6-month contract

Compensation:
$30–$40/hour (rate flexibility based on location)

Overview

A leading life sciences organization is seeking a
Data Management Specialist
to support its Regulatory Affairs and Quality teams in alignment with the European Union In Vitro Diagnostic Regulation (IVDR). This role focuses on collecting, organizing, and maintaining regulatory data related to medical device registrations within the company's Product Data Management System. The position also includes system validation testing and documentation development to ensure long-term data accuracy and compliance.

Key Responsibilities

  • Gather and consolidate IVDR-related regulatory data from internal and external sources
  • Enter and maintain data in the product data management system, ensuring accuracy and compliance with internal standards
  • Develop and document Standard Operating Procedures (SOPs) and work instructions to support sustainable data integrity
  • Collaborate with cross-functional teams including Regulatory Affairs, Quality, R&D, and Supply Chain to ensure data traceability and alignment
  • Support continuous improvement initiatives focused on data quality and process efficiency

Qualifications

Required

  • 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 IVD industry preferred
  • Strong attention to detail and commitment to data accuracy
  • Excellent organizational and analytical skills
  • Clear written and verbal communication skills in English
  • Proficiency in Microsoft Word and Excel

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