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
- 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
- Opportunity to work within a growing, regulated healthcare organisation
- Exposure to global quality systems and regulatory standards
- Competitive salary and benefits package
Document Control Specialist - In Vitro Diagnostics in London employer: Proclinical Group
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, alongside a competitive salary and benefits package that reflects your expertise and dedication. Join a collaborative team that values innovation and continuous improvement, making a real impact in the regulated healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Document Control Specialist - In Vitro Diagnostics in London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your skills as a Document Control Specialist. This will help you stand out and show you're genuinely interested.
✨Tip Number 3
Practice common interview questions related to document control and quality management systems. Be ready to discuss your experience with ISO 13485 and FDA regulations, as these are key to the role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step to engage with us directly.
We think you need these skills to ace Document Control Specialist - In Vitro Diagnostics in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in Document Control and Quality Documentation. Use keywords from the job description, like ISO 13485 and FDA 21 CFR Part 820, to show we’re on the same page.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Share specific examples of how you've managed QMS documentation and any relevant training you've delivered. Let us see your personality and passion for the role!
Showcase Your Attention to Detail:In a role focused on compliance and documentation, attention to detail is key. Make sure your application is free from typos and errors. A polished application reflects your commitment to quality!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of getting noticed. It’s quick and easy, and we can’t wait to see what you bring to the table!
How to prepare for a job interview at Proclinical Group
✨Know Your Standards
Make sure you brush up on ISO 13485 and FDA 21 CFR Part 820 before the interview. Being able to discuss these standards confidently will show that you understand the regulatory environment and can manage QMS documentation effectively.
✨Showcase Your Experience
Prepare specific examples from your previous roles where you've successfully managed document control or quality documentation. Highlight any experience with electronic document management systems, as this is crucial for the role.
✨Demonstrate Attention to Detail
During the interview, be ready to discuss how you ensure accuracy in your work. You might want to share a story about a time when your attention to detail made a significant difference in a project or process.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's quality management processes and how they integrate global QMS. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
