Regulatory Affairs Consultant

Cure Talent; United Kingdom; Remote; GBP 45,000 - 75,000; Full time

Job summary

An innovative consultancy is seeking experienced Regulatory Affairs Consultants with a specialization in IVDs. This fully remote role offers the chance to work on impactful projects, guiding clients through regulatory processes and ensuring compliance with global standards. Join a forward-thinking team dedicated to bringing new diagnostics to market while navigating the complexities of health technology regulations. If you're passionate about making a difference in the MedTech field, this opportunity is perfect for you.

Qualifications

• Proven experience in Regulatory Affairs for IVDs, including IVDR and FDA pathways.
• Strong understanding of IVDR Annexes and requirements for clinical data.

Responsibilities

• Lead development of regulatory strategies for IVDs across various jurisdictions.
• Guide clients through regulatory submissions including CE marking and global dossiers.

Skills

Regulatory Affairs for IVDs

Technical Documentation Writing

Risk Classification Reviews

Performance Evaluation Plans

Attention to Detail

Job description

This range is provided by Cure Talent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

Direct message the job poster from Cure Talent

Connecting the best talent in QARA with Innovative MedTech & STEM Organisations

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!

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Legal, and Consulting

• Industries

  Medical Equipment Manufacturing

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