UDI EUDAMED Data Engineer (Medical Devices)

Job Title: UDI / EUDAMED Data Engineer (Medical Devices)
Location: Raynham MA (Onsite)
Duration: 12 18 Months Contract
Job Description:

We are seeking a detail-oriented professional to support EUDAMED registration activities for medical devices. The ideal candidate will have experience in data extraction regulatory documentation and cross-functional collaboration within the medical device industry.

Key Responsibilities:

• Collect and compile device attribute data for DePuy Synthes products from approved sources to support EUDAMED registration.
• Review labeling and Instructions for Use (IFU) documents to extract UDI-related attributes in compliance with EU MDR requirements.
• Utilize extraction tools (e.g. Scripts AI tools MS Excel) to capture approximately 44 UDI attributes for devices within EUDAMED scope.
• Perform scope analysis and collaborate with Supply Chain Marketing and NPD teams to identify devices requiring EUDAMED registration.
• Author review and approve protocols and reports related to data collection registration and maintenance in DePuy Quality Systems.
• Ensure accuracy compliance and consistency of regulatory data across systems.

Qualifications:

• Bachelors degree in Mechanical or Biomedical Engineering with 3 6 years of experience in the medical device industry
  OR
• Masters degree in Mechanical or Biomedical Engineering with 3 years of relevant experience
• Strong understanding of EU MDR UDI and EUDAMED requirements
• Experience with data extraction analysis tools and regulatory documentation
• Excellent communication and cross-functional collaboration skills
  

  R. Divya Sri Sr. Technical Recruiter

  Address: 6110 McFarland St Dr Alpharetta GA 30004

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  Fusion Life Sciences Technologies LLC