At a Glance
- Tasks: Manage and maintain quality documentation in a regulated healthcare environment.
- Company: Join a growing healthcare organisation focused on in-vitro diagnostics.
- Benefits: Competitive salary, benefits package, and exposure to global quality systems.
- Other info: Great opportunity for career growth in a dynamic team.
- Why this job: Make a real impact in healthcare by ensuring compliance and quality.
- Qualifications: Experience in document control and knowledge of ISO 13485 and FDA regulations.
The predicted salary is between 40000 - 50000 £ per year.
Location: London (fully site-based)
Duration: 12 Month Contract
Pay: Competitive Rate
Proclinical is partnered with a regulated healthcare organisation operating within medical and in-vitro diagnostics. Due to continued expansion they are looking to hire a Document Control Specialist to join their Quality team at their London offices.
This role will be responsible for the day‑to‑day management of Quality Management System (QMS) documentation, ensuring all controlled documents are compliant with ISO 13485 and FDA 21 CFR Part 820 requirements.
Key Responsibilities of the Document Control Specialist
- Manage and maintain controlled QMS documentation in line with internal procedures
- Coordinate document creation, review, approval and distribution workflows
- Monitor document revisions and manage document change orders
- Maintain an accurate and up‑to‑date electronic document management system
- Support global QMS integration and continuous improvement activities
- Deliver document control and quality system training as required
- Liaise with internal teams and external vendors on documentation matters
- Prepare reports and support audit readiness activities
Requirements for the Document Control Specialist
- Previous experience in Document Control / Quality Documentation within a regulated environment
- Working knowledge of ISO 13485:2016 and 21 CFR Part 820
- Experience using electronic document management systems (eDMS)
- Strong attention to detail and excellent organisational skills
- Ability to work independently and collaborate across teams
What's on offer
- Opportunity to work within a growing, regulated healthcare organisation
- Exposure to global quality systems and regulatory standards
- Competitive salary and benefits package
If you are having difficulty in applying or if you have any questions, please contact Neil Walton.
Document Control Specialist - In Vitro Diagnostics in London employer: Proclinical Staffing
Proclinical is an exceptional employer, offering a dynamic work environment in the heart of London where you can contribute to meaningful advancements in healthcare and in-vitro diagnostics. With a strong focus on employee growth, you will have access to training in quality systems and regulatory standards, while enjoying a competitive salary and benefits package that reflects our commitment to your professional development and well-being.
