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- Tasks: Lead regulatory strategies for IVDs and guide 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 dynamic 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 supportive 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 work in IVDs. This can help you gain insights into the latest trends and potentially lead to job referrals.
✨Tip Number 2
Stay updated on the latest regulations and guidelines related to IVDR, UKCA, and FDA pathways. Subscribe to relevant newsletters or join online forums where regulatory changes are discussed. This knowledge will not only enhance your expertise but also demonstrate your commitment to potential employers.
✨Tip Number 3
Consider reaching out directly to current employees at the consultancy you're interested in. A friendly message on LinkedIn can open doors and provide you with insider information about the company culture and what they value in candidates.
✨Tip Number 4
Prepare for interviews by practising how to clearly explain complex regulatory concepts. Use examples from your past experience to illustrate your problem-solving skills and attention to detail. This will help you stand out as a candidate who can effectively communicate with clients.
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 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 regulatory affairs. 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.
Showcase Your Understanding of Regulations: Demonstrate your knowledge of IVDR Annexes and classification rules in your application. This will show the company that you are well-versed in the requirements for clinical and performance data, which is crucial 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 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 and how you overcame them, particularly in a consultancy setting.
✨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.
