Regulatory Affairs Lead (Fractional / Part-Time) — AI-Enabled Medical Devices in Milton Keynes

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.

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