Prelego is an Imperial College London spin-out building AI-enabled Software as a Medical Device (SaMD) products that predict hospital-acquired harm for the NHS and international markets.
We're looking for an experienced regulatory affairs professional to own our multi-jurisdictional compliance strategy across UKCA, CE MDR (Class IIa), FDA (De Novo), DTAC, and DCB0129. This is a hands-on, senior role: you'll build and maintain QMS documentation, lead notified body and FDA interactions, and shape regulatory strategy as we scale from UK deployment to US and EU market entry.
What you'll own:
* QMS build-out and maintenance (ISO 13485, IEC 62304, ISO 14971)
* CE MDR Class IIa technical file preparation and notified body audit management
* UKCA Class I compliance and post-market surveillance
* FDA De Novo submission strategy and pre-submission engagement
* DTAC, DCB0129, and DCB0160 clinical safety compliance for NHS deployment
* Regulatory input into product development lifecycle
What we're looking for:
* 5+ years in regulatory affairs for medical devices, with SaMD / digital health experience strongly preferred
* Direct experience with CE MDR Class IIa or higher classification
* Working knowledge of FDA software device pathways (De Novo, 510(k))
* Familiarity with NHS digital compliance frameworks (DTAC, DCB0129)
* Comfortable operating as the sole regulatory function in a startup, with external advisors to support
Starting as a fractional engagement (2–3 days/week), with a clear path to a permanent in-house role as we approach CE MDR audit and scale commercially.
Prelego is backed by Parkwalk / Imperial College Enterprise Fund and led by a team of clinicians, engineers, and AI researchers. If you want to shape the regulatory foundation of a platform that will change how hospitals prevent avoidable patient harm, get in touch.
📩 Apply via LinkedIn or email []
FULL JOB DESCRIPTION
Role: Regulatory Affairs Lead (Fractional → Permanent)
Reports to: CEO Location: London (hybrid)
Engagement: Fractional (2–3 days/week initially), transitioning to full-time
Compensation: Competitive day rate / salary + equity (SEIS/EMI-eligible options)
About Prelego
Prelego Holdings Limited is an Imperial College London spin-out developing AI-enabled Software as a Medical Device (SaMD) products for NHS patient safety. Our product suite predicts hospital-acquired harm events using a shared Intelligence Layer platform architecture. Our lead product is currently going through active regulatory pathways across UKCA (Class I), CE MDR (Class IIa), and FDA (De Novo).
We are seed-funded, deploying our first product into NHS Trusts via the Federated Data Platform, and preparing for CE MDR first-stage audit in mid-2026 and FDA Pre-Submission engagement.
Role Summary
We need a regulatory affairs professional who can own end-to-end regulatory compliance, strategy, and submission across three jurisdictions (UK, EU, US) and NHS-specific digital compliance frameworks. You will be Prelego's in-house regulatory function, working with external consultants (currently engaged for CE MDR and FDA advisory) but accountable for the integrity and completeness of all regulatory deliverables.
This is not a process-following role. You'll be making regulatory strategy decisions with direct commercial consequences — classification rationale, predicate selection, clinical evidence sufficiency, post-market surveillance design, and regulatory timing relative to commercial milestones.
Responsibilities
Quality Management System
* Build, own, and maintain QMS compliant with ISO 13485, aligned to IEC 62304 (software lifecycle), ISO 14971 (risk management), and IEC 62366 (usability)
* Ensure QMS readiness for notified body audit and FDA inspection
* Manage document control, CAPA, design history files, and internal audit cycles
CE MDR (Class IIa)
* Prepare and maintain technical documentation per MDR Annex II and III
* Manage notified body relationship and audit preparation
* Develop and execute clinical evaluation strategy (MEDDEV 2.7/1 Rev 4 / MDCG guidance)
* Establish and run post-market surveillance system including PMCF
UKCA (Class I)
* Maintain UKCA Class I self-declaration and registration with MHRA
* Monitor UKCA regulatory reform and advise on reclassification implications
FDA (De Novo)
* Own De Novo submission preparation, coordinating with US regulatory advisors
* Manage Pre-Submission (Q-Sub) strategy and FDA correspondence
* Develop clinical evidence packages aligned to FDA expectations for AI/ML SaMD
* Track FDA AI/ML regulatory framework developments and predetermined change control plans
NHS Digital Compliance
* Own DTAC assessment completion and maintenance
* Manage DCB0129 clinical safety case and DCB0160 deployment clinical safety
* Interface with Clinical Safety Officers and NHS Digital compliance requirements
Strategic & Cross-Functional
* Advise product and engineering teams on regulatory requirements during development
* Provide regulatory input into commercial go-to-market timing (UK, EU, US)
* Support investor and partner due diligence on regulatory posture
* Manage relationships with external regulatory consultants and legal advisors
Requirements
Essential
* 5+ years regulatory affairs experience in medical devices
* Direct, hands-on experience preparing CE MDR technical documentation (Class IIa or higher)
* Working knowledge of FDA software device submission pathways
* Strong understanding of ISO 13485 QMS requirements
* Experience with risk management (ISO 14971) and software lifecycle (IEC 62304)
* Ability to work autonomously as the primary regulatory function in a small company
Strongly Preferred
* SaMD / digital health / AI-enabled device experience
* Experience with NHS digital compliance (DTAC, DCB0129/0160)
* Prior experience with FDA De Novo or Pre-Submission process
* Familiarity with MHRA post-Brexit UKCA framework
* Experience in a startup or scale-up environment
Nice to Have
* RAC (Regulatory Affairs Certification) or equivalent
* Experience with clinical evidence strategy for AI/ML devices
* Understanding of FHIR / interoperability standards in a regulatory context
* Prior interaction with Palantir FDP or NHS Trust IT ecosystems
What We Offer
* Equity participation in an early-stage, VC-backed Imperial spin-out
* Direct strategic influence — you will shape regulatory architecture, not execute someone else's plan
* Flexible fractional start with a defined path to permanent
* Access to Imperial College ecosystem and clinical collaborators
* A founding-team-level role in a company building products that measurably reduce patient harm