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: Collaborative team environment with opportunities for professional growth.
- Why this job: Make a real impact in healthcare by ensuring compliance with quality 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 (url removed).
Document Control Specialist - In Vitro Diagnostics in London employer: Proclinical
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 continuous training and development opportunities while working alongside a dedicated team committed to quality and compliance. Enjoy a competitive salary and benefits package as you play a vital role in supporting global quality systems within a rapidly expanding organisation.
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, especially those already working in document control or quality management. A friendly chat can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on ISO 13485 and FDA regulations. We want you to show off your knowledge and how it applies to the role. Practise common interview questions related to document control to boost your confidence.
✨Tip Number 3
Don’t forget to showcase your organisational skills! Bring examples of how you've managed documentation in the past, especially in regulated environments. This will help us see how you can contribute to our Quality team.
✨Tip Number 4
Apply through our website for the best chance at landing the job! It’s the quickest way for us to get your application and start the conversation. Plus, we love seeing candidates who are proactive!
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 is tailored to the Document Control Specialist role. Highlight your experience with ISO 13485 and FDA regulations, as well as any relevant document management systems you've used. 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 quality management in healthcare. Share specific examples of your past experiences that relate to the responsibilities listed in the job description. Let us know why you’re the perfect fit!
Showcase Your Attention to Detail:As a Document Control Specialist, attention to detail is key. In your application, make sure to demonstrate this skill. Whether it's through your CV formatting or the clarity of your writing, we want to see that you can manage documents meticulously.
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of getting noticed. It’s straightforward and ensures your application goes straight to us. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Proclinical
✨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 challenges you faced and how you overcame them, as this will demonstrate your problem-solving skills.
✨Familiarise Yourself with eDMS
If you have experience with electronic document management systems, be ready to discuss it. If not, do a bit of research on common eDMS tools used in the industry. Showing that you're proactive about learning can set you apart.
✨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.
