Diagnostic Documentation Specialist
We are seeking a meticulous Diagnostic Documentation Specialist to support the preparation and review of labelling documentation for diagnostic products. The successful candidate will work closely with our Quality Assurance team to ensure accurate and compliant documentation.
The role involves:
* Reviewing and approving product labels for regulatory compliance
* Populating and reviewing Instructions for Use (IFUs) with technical data
* Maintaining and updating IFU templates to ensure consistency
* Entering and verifying data in our Technical Library (XML files)
* Processing label updates through our document control system
* Assisting with master labelling documents (labels, IFUs, packaging specs)
* Supporting validation activities for our auto-population system
* Uploading approved documentation to our internal and customer-facing platforms
Following all standard operating procedures (SOPs) and regulatory requirements is crucial.
Qualifications and Skills
We require someone with:
* A Level 5 qualification in Science, Engineering, Pharma or QA
* Ideal experience: 2+ years in a regulated medical or diagnostics setting
* Familiarity with Microsoft Office tools; knowledge of Adobe InDesign and NiceLabel Pro is beneficial
* Understanding of regulatory frameworks like FDA 21 CFR Part 820 and ISO 13485
This role demands strong attention to detail and a proactive approach to work. Excellent teamwork and communication skills are essential.
What We Offer
We provide:
* 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
* A supportive, inclusive culture rooted in our core values: Passion | Curiosity | Integrity | Brilliance | Respect
We value diversity and encourage applicants from all backgrounds to apply. Reasonable accommodations can be made throughout the recruitment process upon request.