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- Tasks: Lead regulatory strategies for IVDs and support clients through submissions.
- Company: Join a fast-growing consultancy supporting innovative MedTech firms 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 health technology innovation.
- 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 43200 - 72000 £ 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 Senior 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!
Senior Regulatory Affairs Consultant employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Consultant
✨Tip Number 1
Familiarise yourself with the latest IVDR regulations and guidelines. Being well-versed in these will not only boost your confidence during discussions but also demonstrate your commitment to staying updated in this fast-evolving field.
✨Tip Number 2
Network with professionals in the MedTech industry, especially those who have experience in regulatory affairs. Engaging in conversations with them can provide valuable insights and may even lead to referrals or recommendations for the role.
✨Tip Number 3
Prepare to discuss specific projects you've worked on that relate to IVDs and regulatory submissions. Highlighting your hands-on experience will help you stand out as a candidate who can hit the ground running.
✨Tip Number 4
Showcase your ability to communicate complex regulatory concepts clearly. During interviews, practice explaining technical details in a straightforward manner, as this skill is crucial for guiding clients through the regulatory process.
We think you need these skills to ace Senior 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 your familiarity with IVDR, FDA, and UKCA pathways, as well as any consultancy experience you may have.
Craft a Compelling Cover Letter: In your cover letter, explain why you're passionate about the MedTech sector and how your skills align with the role. Mention specific projects or experiences that demonstrate your ability to lead regulatory strategies and engage with clients.
Showcase Your Writing Skills: Since exceptional writing skills are crucial for this role, consider including examples of Technical Documentation you've written or reviewed. This could be a brief summary of a project where you prepared Performance Evaluation Plans or Technical Documentation.
Highlight Attention to Detail: Provide examples in your application that showcase your attention to detail. This could include instances where you successfully identified gaps in regulatory submissions or improved documentation processes for clients.
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 Consultancy Experience
If you have consultancy experience, highlight it! Discuss how you've managed multiple projects and adapted to fast-paced environments. If not, share relevant experiences that showcase your ability to work under pressure and deliver results.
✨Prepare for Technical Questions
Expect questions about Technical Documentation, Performance Evaluation Plans, and risk classification reviews. Prepare to explain your approach to drafting and reviewing these documents, as well as any challenges you've faced.
✨Engage with Real-World Scenarios
Be ready to discuss real-world scenarios where you've guided clients through regulatory submissions or engaged with Notified Bodies. This will demonstrate your practical understanding of the role and your problem-solving skills.
