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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 making a difference in health technology.
- Qualifications: Experience in Regulatory Affairs for IVDs and strong writing skills required.
- Other info: Opportunity to work on multiple high-impact projects in a dynamic environment.
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 employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Consultant
✨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 opportunities related to IVDs and regulatory consultancy.
✨Tip Number 2
Stay updated on the latest changes in IVDR, UKCA, and FDA regulations. Follow relevant regulatory bodies and subscribe to newsletters to ensure you are well-informed about any new guidelines or requirements that could impact your role.
✨Tip Number 3
Consider joining professional associations related to regulatory affairs. Being part of these groups can provide access to exclusive job postings, resources, and a community of like-minded professionals who can offer support and advice.
✨Tip Number 4
Prepare for interviews by familiarising yourself with common regulatory scenarios and case studies in the IVD space. Be ready to discuss how you would approach specific challenges or projects, showcasing your problem-solving skills and expertise.
We think you need these skills to ace Regulatory Affairs Consultant
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 Relevant 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 colleagues.
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
✨Showcase Your Regulatory Knowledge
Make sure to brush up on the latest regulations related to IVDs, including IVDR, UKCA, and FDA pathways. Be prepared to discuss specific examples of how you've navigated these regulations in your previous roles.
✨Demonstrate Your Attention to Detail
Given the nature of regulatory affairs, attention to detail is crucial. During the interview, highlight instances where your meticulousness has led to successful outcomes, such as error-free documentation or successful submissions.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about challenges you've faced in regulatory submissions or client interactions and be ready to explain how you handled them.
✨Communicate Complex Concepts Clearly
You’ll need to explain intricate regulatory concepts to clients who may not have a technical background. Practice articulating complex ideas in simple terms, showcasing your ability to bridge the gap between technical and non-technical stakeholders.
