Senior Medical Device UDI Labeling Specialist

3 days ago


Mumbai, Maharashtra, India Vision Achievement Full time

Job Overview

Vision Achievement is seeking a detail-oriented Medical Device UDI Labelling Specialist to support our client organization in achieving compliance with global UDI requirements.

Responsibilities

  • Design and implement UDI labels for medical devices, ensuring compliance with global regulatory requirements.
  • Collaborate with cross-functional teams to gather label content, including device identifiers, production information, and regulatory symbols.
  • Ensure labels meet global standards such as GS1, HIBC, and ICCBBA specifications.
  • Stay up-to-date on UDI regulations for all applicable regions, including FDA, EU MDR/IVDR, and other jurisdictions.
  • Conduct audits of existing labeling to identify and address non-compliance.
  • Work with IT and quality teams to implement and maintain labeling systems, including enterprise resource planning (ERP) and labeling software.
  • Test and validate label designs to ensure readability, durability, and compliance with scanning requirements.
  • Create and maintain comprehensive documentation, including label specifications, templates, and approval records.
  • Provide support for internal and external audits by maintaining accurate records of label-related activities.

Qualifications

  • Bachelor's degree in regulatory affairs, engineering, life sciences, or a related field.
  • Proven experience with UDI labeling for medical devices, including familiarity with global UDI requirements.
  • Experience with regulatory submissions and device registration processes.
  • Hands-on experience with labeling software such as BarTender, Loftware, or similar tools.

Contract Details

  • Temporary contracts (project-based, potentially recurrent).
  • Remote or on-site, based on project requirements.
  • Competitive daily rate: $100-$150 per day, commensurate with experience.


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