Medical Device UDI Labeling Expert
hace 2 semanas
Job Summary: We are seeking a detail-oriented Medical Device UDI Labeling Specialist to support our client organization in achieving compliance with global UDI requirements.
Overview: Vision Achievement is looking for an experienced expert to lead the implementation of UDI-compliant labeling solutions for medical devices. The ideal candidate will have a deep understanding of global regulatory requirements, including those mandated by the FDA, EU MDR/IVDR, and other international frameworks.
About the Job: As a Medical Device UDI Labeling Specialist, you will be responsible for designing and implementing UDI labels for medical devices, ensuring compliance with global regulatory standards. You will work closely with cross-functional teams to gather label content, including device identifiers, production information, and regulatory symbols. Your expertise will ensure that labels meet global standards such as GS1, HIBC, and ICCBBA specifications.
Your Key Responsibilities:
- Design and implement UDI labels for medical devices
- Collaborate with cross-functional teams to gather label content
- Ensure labels meet global standards
- Stay up-to-date on UDI regulations for all applicable regions
- Conduct audits of existing labeling to identify and address non-compliance
- Work with IT and quality teams to implement and maintain labeling systems
- Test and validate label designs
- Create and maintain comprehensive documentation
- Provide support for internal and external audits
- Train internal teams on UDI labeling processes
Requirements: To be successful in this role, you will need:
Bachelor's degree in Regulatory Affairs, Engineering, Life Sciences, or a related field
Proven experience with UDI labeling for medical devices
Hands-on experience with labeling software
Strong knowledge of global UDI standards
Proficiency in data management and ERP systems
Exceptional attention to detail and organizational skills
Strong communication and collaboration abilities
$120,000 - $150,000 per year, depending on experience
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