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- Tasks: Lead regulatory strategies for IVDs and support clients through submissions.
- Company: Join a fast-growing consultancy supporting innovative MedTech companies in the UK.
- Benefits: Enjoy a fully remote role with flexible hours and impactful projects.
- Why this job: Be part of a forward-thinking team shaping the future of health technology.
- Qualifications: Experience in Regulatory Affairs for IVDs and strong writing skills required.
- Other info: Opportunity to work on multiple projects and engage with global regulations.
The predicted salary is between 36000 - 60000 £ per year.
Cure Talent is delighted to be working with a fast-growing specialist consultancy that delivers tailored Quality and Regulatory support to some of the UK’s most exciting MedTech innovators. Due to their exceptional continued growth, we’re looking for experienced Regulatory Affairs Consultants with an IVD specialism to support a broad range of clients – from start-ups preparing for CE marking under IVDR, to established firms expanding into new global markets. This is a flexible, fully remote role that offers the opportunity to work on multiple high-impact projects while collaborating with a forward-thinking team of regulatory professionals.
You will:
- Lead or support the development of regulatory strategies for IVDs across IVDR, UKCA, FDA, and other global jurisdictions.
- Perform IVDR gap assessments, risk classification reviews, and prepare Technical Documentation in line with current MDCG guidance.
- Draft and review Performance Evaluation Plans and Reports, including clinical and analytical performance justification.
- Guide clients through regulatory submissions including CE marking files, 510(k), De Novo, and global dossiers.
- Provide ongoing lifecycle support for post-market surveillance, vigilance, and periodic updates to regulatory documentation.
- Engage with Notified Bodies and Competent Authorities, supporting client responses and submission strategy.
The ideal candidate will have:
- Proven experience in Regulatory Affairs for IVDs (IVDR, FDA, or UKCA pathways).
- Strong understanding of IVDR Annexes, classification rules, and requirements for clinical and performance data.
- Proven ability to write and review Technical Documentation, including GSPR, PMS, and PERs.
- Experience working in a fast-paced, multi-project environment – consultancy experience is highly desirable, though not essential.
- Exceptional attention to detail, writing skills, and the ability to explain complex concepts clearly to clients.
This role offers autonomy, variety, and impact, allowing you to work closely with clients bringing new diagnostics to market while keeping pace with changing global regulations. If you're looking for an exciting opportunity to be part of a rapidly expanding company at the forefront of health technology innovation, get in touch today!
Regulatory Affairs Consultant (United Kingdom) employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Consultant (United Kingdom)
✨Tip Number 1
Network with professionals in the MedTech and regulatory affairs sectors. Attend industry conferences, webinars, or local meetups to connect with others who may have insights or job leads related to Regulatory Affairs Consultant roles.
✨Tip Number 2
Stay updated on the latest changes in IVDR, UKCA, and FDA regulations. Subscribe to relevant newsletters or follow key organisations on social media to ensure you’re well-informed and can discuss current trends during interviews.
✨Tip Number 3
Consider reaching out directly to current employees at the consultancy you’re interested in. A friendly message on LinkedIn can provide you with insider information about the company culture and expectations for the role.
✨Tip Number 4
Prepare to discuss specific projects you've worked on that relate to IVDs and regulatory submissions. Being able to articulate your hands-on experience will demonstrate your capability and fit for the role.
We think you need these skills to ace Regulatory Affairs Consultant (United Kingdom)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Regulatory Affairs, particularly with IVDs. Emphasise any relevant projects you've worked on, especially those involving IVDR, FDA, or UKCA pathways.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of the role and the company. Mention specific experiences that demonstrate your ability to lead regulatory strategies and your familiarity with Technical Documentation.
Highlight Key Skills: In your application, focus on your attention to detail and writing skills. Provide examples of how you've successfully communicated complex regulatory concepts to clients or stakeholders.
Showcase Your Consultancy Experience: If you have consultancy experience, make sure to highlight it. Discuss how you've managed multiple projects and adapted to fast-paced environments, as this is highly desirable for the role.
How to prepare for a job interview at Cure Talent
✨Know Your Regulations
Make sure you have a solid understanding of the IVDR, UKCA, and FDA regulations. Brush up on the specific requirements for IVDs and be prepared to discuss how you've applied this knowledge in your previous roles.
✨Showcase Your Experience
Be ready to share specific examples from your past work that demonstrate your expertise in regulatory affairs. Highlight any experience with CE marking, performance evaluation plans, or client interactions that showcase your ability to guide clients through complex processes.
✨Demonstrate Attention to Detail
Since this role requires exceptional attention to detail, prepare to discuss how you ensure accuracy in your work. You might want to mention any tools or methods you use to maintain high standards in documentation and compliance.
✨Engage with Questions
Prepare thoughtful questions about the company's projects and their approach to regulatory challenges. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
