Medical Device UDI Compliance Expert
1 week ago
We are seeking a detail-oriented Medical Device UDI Labelling Specialist to support our client organization in achieving compliance with global UDI requirements. This role focuses on the design, development, and implementation of UDI-compliant labelling solutions for medical devices.
About Vision AchievementVision Achievement is a leading provider of regulatory compliance solutions for the medical device industry. We are dedicated to helping our clients achieve compliance with global regulations and standards.
Key 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.
- Bachelors 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.
- Knowledge of global UDI standards (GS1, HIBC, ICCBBA).
- Proficiency in data management and ERP systems related to labeling.
- Competitive daily rate, commensurate with experience.
- Temporary contracts (project-based, potentially recurrent).
- Remote or on-site, based on project requirements.
Please note that this job description may be subject to change. The estimated salary range for this position is $100-$120 per hour, depending on experience and location.
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