JOB DESCRIPTION
Project Compliance Officer
Responsible to: Head of Laboratory Operations
Key Relationships
Quality, Warehouse and Clinical teams, Program manager
Purpose of Role
Responsible for validating new laboratory analysers, assays, and operations systems while ensuring compliance with ISO 15189, ISO 27001, ISO 9001, ISO 14001, and Medical Device regulations to support safe, secure, high-quality operations
Location
Head Office, Preventx Ltd, MBP5, Meadowhall Business Park, Carbrook Hall Road, Sheffield S9 2EQ
Application closing date: 30 September 2026
About Preventx
Preventx is a fast-growing technology company with more than 13 years’ experience as the market leader in online sexual health and STI sampling services. We work with over 60 local authority regions and NHS providers across the UK and are a trusted partner of the NHS. Our services have enabled around 1.7m people to test for STIs, improving public health whilst saving money. With recent investment, the company is committed to growth and continuous improvement. You will join a supportive team where you’ll be encouraged to do your best work and define the way we use data in the business.
This role ensures that all validation and change activities meet regulatory, accreditation, and manufacturer requirements. The post holder supports the Operations and Quality teams in maintaining compliance with ISO 15189, ISO 27001, ISO 9001, ISO 14001, and Medical Device regulatory frameworks, ensuring safe, secure, and high‑quality laboratory services
Key Responsibilities
- Plan, write, and execute validation and verification protocols for new analysers, assays, methodologies, and laboratory systems.
- Perform validation studies including accuracy, precision, linearity, detection limits, measurement uncertainty, and reference interval verification.
- Document all validation activities to meet ISO 15189 and internal QMS requirements.
- Lead IQ/OQ/PQ processes for new equipment and software.
- Support operational teams to ensure continuous compliance with accreditation standards.
- Maintain documentation, validation records, and equipment files in line with accreditation requirements.
- Participate in internal audits, external assessments, and CAPA processes.
- Support competency assessments and training related to new instruments and assays.
- Contribute to compliance efforts across ISO 27001 (information security), ISO 9001 (quality management), and ISO
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Project Compliance Officer in Sheffield employer: preventx
Preventx is an exceptional employer located in the vibrant Meadowhall Business Park, Sheffield, offering a part-time Governance Administrator role within a dynamic digital healthcare environment. With a strong commitment to employee wellness, structured career development pathways, and a collaborative culture that values diversity and inclusion, Preventx empowers its staff to thrive while making a meaningful impact in sexual health diagnostics. Join us to be part of a team that prioritises innovation and personal growth in a supportive workplace.