Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- 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 the future of 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 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
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 Senior 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
Prepare to demonstrate your experience with specific IVD projects. Be ready to discuss your role in regulatory submissions, gap assessments, and any successful strategies you've implemented that led to positive outcomes for clients.
✨Tip Number 4
Familiarise yourself with the consultancy's client base and their products. Understanding their needs and challenges will allow you to tailor your discussions and show how your expertise can directly benefit their operations.
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: Write a cover letter that showcases your passion for MedTech and your understanding of the regulatory landscape. Mention specific projects or experiences that demonstrate your ability to lead regulatory strategies and engage with clients effectively.
Highlight Relevant Skills: In your application, focus on your writing skills and attention to detail. Provide examples of how you've successfully drafted Technical Documentation or guided clients through regulatory submissions, as these are key aspects of the role.
Showcase Your Problem-Solving Abilities: Discuss instances where you've navigated complex regulatory challenges or provided innovative solutions for clients. This will illustrate your capability to thrive in a fast-paced, multi-project environment.
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 simultaneously and how you’ve adapted to the fast-paced environment typical of consultancy work.
✨Prepare for Technical Questions
Expect questions about Technical Documentation, Performance Evaluation Plans, and risk classification reviews. Be ready to explain your approach to drafting and reviewing these documents, as well as any challenges you've faced.
✨Engage with Real-World Scenarios
Be prepared to discuss real-world scenarios where you've had to engage with Notified Bodies or Competent Authorities. Sharing specific examples will demonstrate your practical experience and problem-solving skills.
