Senior Medical Device UDI Labeling Specialist
3 days ago
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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