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: Opportunity for career growth in a dynamic and supportive team.
- Why this job: Make a real impact in healthcare by ensuring compliance with industry standards.
- Qualifications: Experience in document control and knowledge of ISO 13485 and FDA regulations.
The predicted salary is between 30000 - 40000 € 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 at n.walton@proclinical.com.
Document Control Specialist - In Vitro Diagnostics 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 comprehensive training and development opportunities while working alongside a dedicated team committed to quality and compliance. Enjoy a competitive salary and benefits package, all within a culture that values collaboration and continuous improvement.
StudySmarter Expert Advice🤫
We think this is how you could land Document Control Specialist - In Vitro Diagnostics
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend relevant events, and connect with people 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 tailor your responses and show them you're the perfect fit!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or family to get comfortable with common questions. Focus on showcasing your experience with ISO 13485 and FDA regulations, as these are key for 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 the initiative to engage directly with us.
We think you need these skills to ace Document Control Specialist - In Vitro Diagnostics
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Document Control Specialist role. Highlight your experience with QMS documentation and any relevant ISO standards. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how your background fits. We love seeing enthusiasm, so let your personality come through!
Showcase Your Attention to Detail:As a Document Control Specialist, attention to detail is key. Make sure your application is free from typos and errors. We appreciate candidates who take the time to present their best work!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the easiest way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
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 navigate it effectively.
✨Showcase Your Experience
Prepare specific examples from your previous roles where you've managed QMS documentation or worked with eDMS. Highlighting your hands-on experience will demonstrate your capability and readiness for the role.
✨Be Organised
Since this role requires strong organisational skills, consider bringing a portfolio of your work or a structured outline of your past projects. This will not only impress your interviewers but also give them a clear view of your attention to detail.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's quality systems and how they integrate globally. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
