Job Description

Are you ready to play your part in changing healthcare and empowering patients worldwide? At Sapphiros, you'll be part of a mission-driven team at the forefront of innovative diagnostics.

Are you:

Passionate for improving healthcare and patient outcomes? Organised, proactive and have experience supporting clinical projects? Experienced with working with clinical, regulatory or quality teams?
If so then get ready to meet your new team! Your work will help bring accessible, life-changing health solutions to people around the world.

Overview

At Sapphiros, we're on a mission to revolutionise diagnostics and put testing directly into the hands of people around the world. As part of our Clinical & Regulatory Affairs team, you will help turn innovative ideas into real-world studies and products that change lives through supporting clinical trials and research studies.

Beyond clinical operations, you will also collaborate on Regulatory and Quality work, supporting with the preparation of regulatory and QMS documentation.

What you'll be doing:

Working closely with the clinical project team to help design, plan, and run clinical trials and research studies -- including supporting activities

on site

and seeing first-hand how studies come to life Drafting, reviewing, and keeping essential clinical documents and protocols up to date, ensuring everything is audit-ready Coordinating and preparing regulatory submissions so our studies stay on track and compliant Diving into scientific literature and helping identify potential clinical sites and investigators Organising team meetings, creating agendas and capturing clear, actionable minutes Acting as a connector across the company -- you'll get to work with colleagues from Clinical, Regulatory, Quality and other teams, as well as external partners -- helping to keep projects moving forward

What you'll bring to the team

Hands-on experience supporting IVD clinical trials, plus knowledge of

ICH GCP

,

ISO 14155

, and other relevant standards Familiarity with

ISO 13485 Quality Management Systems

and what's involved in audits and inspections A talent for keeping things organised and moving forward, even when juggling multiple tasks Great communication skills and confidence working with colleagues, external partners, and investigators A proactive, solutions-focused approach that helps the team anticipate and overcome challenges Solid IT skills (Word, Excel, PowerPoint) and the ability to pick up new systems quickly

Ready to help us shape the future of diagnostics?

Apply now and be part of something that truly matters.

Job Types: Temporary, Fixed term contract, Temp to perm
Contract length: 6 months

Pay: 40,000.00-46,500.00 per year

Benefits:

Company events Company pension Discounted or free food Enhanced maternity leave Financial planning services Free flu jabs Free parking Health & wellbeing programme Life insurance On-site parking Private dental insurance Private medical insurance Referral programme Sick pay Transport links Work from home
Schedule:

Monday to Friday
Application question(s):

Do you have knowledge of ICH GCP and ISO 14155
Experience:

hands-on clinical projects for medical devices: 1 year (required) Quality or Regulatory: 1 year (required)
Work Location: Hybrid remote in Essex CB10 1XL

Application deadline: 14/07/2025
Reference ID: CPA - Sapphiros