Independent Contractor: Medical Device UDI Labelling Specialist Overview We are seeking a detail-oriented independent Medical Device UDI (Unique Device Identification) Labelling contractor to support our client organization in achieving compliance with global UDI requirements, including those mandated by the FDA, EU MDR/IVDR, and other international regulatory frameworks.
This role focuses on the design, development, and implementation of UDI-compliant labelling solutions for medical devices.
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 p-to-date on UDI regulations for all applicable regions, including FDA, EU MDR/IVDR, and other jurisdictions.
- Ensure all labeling solutions align with regulatory requirements and industry best practices.
- 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.
- Train internal teams on UDI labeling processes, standards, and tools.
- Act as a subject matter expert for UDI-related queries and challenges.
- Identify and implement process enhancements to streamline UDI label development and compliance.
- Develop templates, guidelines, and standard operating procedures (SOPs) to ensure consistent labeling practices.
Qualifications - 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.
- Strong understanding of barcoding and scanning technologies.
- Exceptional attention to detail and organizational skills.
- Strong communication and collaboration abilities, ability to consult with flexibility.
- Experience with EU EUDAMED UDI database submissions.
- Familiarity with ISO standards related to medical device labeling.
- Certification in regulatory affairs or medical device quality systems.
Contract - Temporary contracts (project-based, potentially recurrent).
- Remote or on-site, based on project requirements.
- Competitive daily rate, commensurate with experience.
Summary If you have expertise in medical device labeling and are passionate about ensuring global compliance, we encourage you to apply.
Your skills will contribute directly to patient safety and regulatory adherence worldwide.
Consulting Role: Independent consultants only (with registered business) Business to business relationship Expenses paid (pre-approved by client)