Project Compliance Officer

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 14001 (environmental management).
• Ensure laboratory systems and processes adhere to Medical Device regulatory requirements
• Maintain required technical documentation for medical devices and analysers.
• Provide technical expertise during installation, commissioning, and troubleshooting of new analysers or assays.
• Collaborate with laboratory, quality, IT, and supplier teams to ensure smooth implementation of new systems.
• Support change control, risk assessments, and incident investigations.
• Provide training and guidance to staff on validation processes and new technologies
• Identify opportunities to improve validation processes, workflows, and documentation.
• Contribute to service improvement projects, process optimisation, and quality initiatives.
• Support the development and review of SOPs related to validation and equipment management.

Person Specification

The preferred candidate will have the following experience, abilities, and aptitudes:

Criteria

Essential

Desirable

Qualification

·         Bachelor’s degree or equivalent experience.

Knowledge and

Experience

·         Experience in laboratory,

·         Experience or knowledge of laboratory or healthcare processes and standards.

·         Experience with H&S regulations/standards.

·         Strong understanding of ISO 15189 accreditation requirements.

·         Experience in validation/verification of laboratory analysers, assays, or diagnostic systems.

·         Ability to write and execute validation protocols, including IQ/OQ/PQ and method validation studies.

·         Knowledge of laboratory quality management systems (QMS).

·         Minimum 2 years’ laboratory experience.

·         Experience supporting compliance with ISO 27001, ISO 9001, and ISO 14001.

·         Knowledge of Medical Device Regulations / IVDR or device registration requirements.

·         Experience participating in internal or external audits

·         Familiarity with laboratory information systems (LIMS)

Skills

·         Excellent technical documentation and report‑writing skills.

·         Understanding of key analytical concepts (accuracy, precision, linearity, uncertainty, detection limits, etc.).

·         Ability to interpret manufacturer documentation and regulatory requirements.

·         Strong problem‑solving and analytical skills.

·         Effective communication skills for cross‑functional collaboration.

·         Strong organisation and project management skills.

·         Driven and determined to achieve results.

·         Statistical analysis skills for method evaluation.

·         Ability to deliver training to laboratory or technical staff.

·         Experience interacting with equipment suppliers or technical service teams

·         Knowledge of environmental and sustainability considerations in laboratory operations.

This job description is not exhaustive and serves only to highlight the main requirements of the post holder.  The line manager may stipulate other reasonable requirements.  The job description will be reviewed regularly and may be subject to change.

Equity, Diversity & Inclusion at Preventx

At Preventx, we believe diversity drives innovation and inclusion strengthens our impact. We’re committed to creating a workplace that values individual differences and fosters a culture of respect, belonging, and growth.

We welcome applications from people of all backgrounds, identities, and experiences—including those from underrepresented communities. If you need any support with your application or adjustments during the recruitment process, we’re here to help.