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Diagnostic Documentation Specialist
2 weeks ago
We are seeking a Quality Assurance Label Specialist to join our team. The ideal candidate will have strong attention to detail, excellent communication skills and experience in regulated medical or diagnostics settings.
Job DescriptionThis role is responsible for preparing and reviewing labelling documentation for diagnostic products, ensuring accuracy and compliance.
- Review and approve lot-specific product labels
- Populate and review Instructions for Use (IFUs) with accurate technical data
- Maintain and update IFU templates to ensure consistency
- Enter and verify data in our Technical Library (XML files)
- Process label updates through our document control system
- Assist with master labelling documents (labels, IFUs, packaging specs)
- Support validation activities for our auto-population system
- Upload approved documentation to our internal and customer-facing platforms
- Follow all SOPs and regulatory requirements
To succeed in this role, you will need:
- A Level 5 qualification (or equivalent) in Science, Engineering, Pharma or QA
- Ideal 2+ years' experience in a regulated medical or diagnostics setting
- Familiarity with Microsoft Word and Excel; knowledge of Adobe InDesign and NiceLabel Pro is a plus
- A basic understanding of regulatory frameworks like FDA 21 CFR Part 820, ISO 13485, IVDR
We offer a range of benefits, including:
- 25 days annual leave
- Health allowance and life assurance
- Retail discounts
- Free Employee Assistance Programme
- Recognition and reward schemes
- Ongoing career development and progression opportunities
We foster a culture of inclusion and collaboration, believing that diverse perspectives lead to better outcomes.