Senior Regulatory Affairs Consultant

Cure Talent; United Kingdom; Remote; GBP 50,000 - 80,000; Full time

Job summary

Join a fast-growing consultancy at the forefront of health technology innovation! This exciting remote role as a Senior Regulatory Affairs Consultant allows you to lead regulatory strategies for IVDs, engage with global clients, and navigate complex regulations. Collaborate with a dynamic team while enjoying autonomy and the chance to impact the market with innovative diagnostics. If you have a passion for regulatory affairs and want to be part of a company that values your expertise, this is the opportunity for you!

Qualifications

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

Responsibilities

• Lead development of regulatory strategies for IVDs across multiple jurisdictions.
• Prepare Technical Documentation in line with current MDCG guidance.

Skills

Regulatory Affairs for IVDs

Technical Documentation Writing

Attention to Detail

Client Communication

Risk Classification Reviews

Education

Degree in Life Sciences or related field

Job description

3 days ago Be among the first 25 applicants

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 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!

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Legal, and Consulting

• Industries

  Medical Equipment Manufacturing

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