Senior Regulatory Affairs Consultant

JR United Kingdom; United Kingdom; Remote; GBP 45,000 - 80,000; Full time

Job summary

Join a fast-growing consultancy at the forefront of health technology innovation. As a Senior Regulatory Affairs Consultant specializing in IVDs, you'll lead regulatory strategies, perform assessments, and guide clients through submissions. This fully remote role offers the chance to work on impactful projects with a collaborative team, ensuring compliance with global regulations. If you're ready to make a difference in the MedTech space, 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 various jurisdictions.
• Guide clients through regulatory submissions including CE marking files.

Skills

Regulatory Affairs for IVDs

Technical Documentation Writing

Risk Classification Reviews

Performance Evaluation Plans

Post-Market Surveillance

Job description

Social network you want to login/join with:

Senior Regulatory Affairs Consultant, united kingdom

col-narrow-left

Client:

Cure Talent

Location:

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Views:

4

Posted:

05.05.2025

Expiry Date:

19.06.2025

col-wide

Job Description:

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!