Job Title

Cure Talent is delighted to be working with a fast-growing specialist consultancy that delivers tailored Quality and Regulatory support to some of the UKs most exciting MedTech innovators.Due to their exceptional continued growth, were 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!