At a Glance
- Tasks: Update and maintain quality and regulatory documentation for medical devices.
- Company: Dynamic medical device company offering remote work opportunities.
- Benefits: Competitive hourly rate, flexible remote working, and contract outside IR35.
- Other info: Perfect for detail-oriented professionals seeking flexibility and growth.
- Why this job: Join a growing industry and make a real impact in healthcare.
- Qualifications: Experience in medical devices and strong QMS knowledge required.
The predicted salary is between 40 - 60 £ per hour.
Contract Opportunity – QARA Specialist (Medical Devices)
Location: Fully Remote (UK-based preferred)
Commitment: 3 days per week
Rate: £40–£60 per hour (Outside IR35)
Contract Type: Contract
We are seeking an experienced Quality Assurance & Regulatory Affairs (QARA) Specialist to support our medical device operations on a contract basis. This is a fully remote role requiring 3 days per week, focused primarily on updating, maintaining, and improving quality and regulatory documentation.
Key Responsibilities:
- Update and maintain Quality Management System (QMS) documentation
- Review and revise technical files and regulatory documentation
- Ensure compliance with MDD, MDR, and FDA requirements
- Support internal quality processes and document control activities
- Assist with audit readiness and regulatory submissions where required
- Identify gaps in documentation and implement corrective updates
Requirements:
- Proven experience in the medical device industry (essential)
- Strong hands-on QMS experience (ISO 13485 preferred)
- Demonstrable experience working with MDD and MDR regulations
- Working knowledge of FDA regulations (21 CFR Part 820)
- Experience updating technical documentation and quality records
- Strong attention to detail and ability to work independently
- Excellent written documentation skills
What We Offer:
- £40–£60 per hour (depending on experience)
- Outside IR35 contract
- Flexible, fully remote working
- Opportunity to support a growing and dynamic medical device environment
If you are a detail-oriented QARA professional with strong regulatory knowledge and documentation expertise, we would love to hear from you. To apply, please send your CV and availability details via LinkedIn!
Regulatory Specialist in City of London employer: Maclivaro Limited
As a fully remote employer, we offer an exceptional work-life balance and the flexibility to work from anywhere in the UK. Our commitment to employee growth is reflected in our dynamic medical device environment, where you will have the opportunity to enhance your skills while contributing to meaningful projects that impact healthcare. Join us for a rewarding contract experience that values your expertise and fosters a culture of collaboration and innovation.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Specialist in City of London
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the lookout for QARA roles. You never know who might have the inside scoop on a great opportunity.
✨Tip Number 2
Get your LinkedIn game on point! Make sure your profile highlights your experience with QMS and regulatory documentation. Engage with relevant content and connect with industry professionals to boost your visibility.
✨Tip Number 3
Prepare for virtual interviews by brushing up on your knowledge of MDD, MDR, and FDA regulations. Practice answering common interview questions related to quality assurance and regulatory affairs to showcase your expertise.
✨Tip Number 4
Don't forget to apply through our website! We love seeing candidates who are proactive and passionate about joining our team. Plus, it makes it easier for us to keep track of your application.
We think you need these skills to ace Regulatory Specialist in City of London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in the medical device industry and showcases your hands-on QMS experience. We want to see how your skills align with the role, so don’t be shy about emphasising your regulatory knowledge!
Show Off Your Documentation Skills:Since excellent written documentation skills are a must for this role, include examples of your previous work that demonstrate your attention to detail. We love seeing how you’ve updated and maintained quality and regulatory documentation in the past.
Be Clear and Concise:When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and make sure your key achievements stand out. This will help us quickly see why you’re a great fit!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications better and ensures you don’t miss any important updates from us!
How to prepare for a job interview at Maclivaro Limited
✨Know Your Regulations
Make sure you brush up on the MDD, MDR, and FDA regulations before your interview. Being able to discuss these in detail will show that you’re not just familiar with them, but that you truly understand their implications in the medical device industry.
✨Showcase Your QMS Experience
Prepare specific examples of how you've updated and maintained Quality Management System documentation in the past. Highlight your hands-on experience with ISO 13485 and any challenges you faced, along with how you overcame them.
✨Demonstrate Attention to Detail
Since this role requires a strong attention to detail, be ready to discuss how you ensure accuracy in your work. You might even want to bring along a sample of your documentation (if possible) to illustrate your meticulous approach.
✨Be Ready for Scenario Questions
Expect scenario-based questions where you’ll need to identify gaps in documentation or suggest corrective actions. Practise articulating your thought process clearly, as this will demonstrate your problem-solving skills and regulatory knowledge.
