Lead Quality

About Eno Health

Eno Health is an AI-powered platform designed to be the ultimate decision-support system for healthcare providers seeking to facilitate personalised care and long-term wellness for patients. We are building a compliant, secure, and European-sovereign biomedical AI solution for personalised healthcare. The platform streamlines practitioners' workflows and patient data processing, enabling faster, more precise clinical decisions.

Role Description

You will build ENO's quality and regulatory function from a blank page as we progress from a wellness position to a medical solution. You are expected to be designing the system itself: a lean, software-native ISO 13485 QMS for a company that ships continuously, uses AI-assisted development under named human review, and refuses to accept that regulated has to mean slow.

The regulatory scope contains a Class I launch moving to Class IIa SaMD under EU MDR, IEC 62304 software lifecycle, ISO 14971 risk management, information-security and AI-management certifications (ISO 27001, ISO 42001) running in parallel, EU AI Act obligations for a high-risk system, and an EMEA remit from day one: our first Gulf-region launch is planned for the UAE in 2027, with further Middle East expansion behind it. You will own regulatory strategy across that footprint, and you will be the person who turns the stack from a threat into a moat.

This is a builder's role for a pragmatist. If your instinct is that a good QMS is the smallest set of controls that actually changes behaviour (and that evidence should fall out of the way people work rather than be written after the fact), you will recognise this job.

You will work with everyone: engineering on lifecycle evidence, clinical leadership on the clinical evaluation, product on claims and intended purpose, the founders on regulatory strategy and certification sequencing. Expect to spend real time inside the product and the codebase's release machinery (this role fails if it is practised from a document management system at arm's length).

You will represent ENO to notified bodies, certification auditors, and competent authorities in the EU and, as the UAE entry progresses, in the Gulf region, where our per-country sovereign data architecture is designed to meet local data-residency expectations. This is a full-time hybrid role based in the Brussels Metropolitan Area, with some flexibility for remote work, and regular travel to the UAE.

Qualifications

• You have taken a software medical device through EU MDR Class IIa (or higher) certification; ideally more than once, and ideally including authorship of the technical file, not only its maintenance.
• Working command of the standards this role lives in: ISO 13485, IEC 62304, ISO 14971, IEC 62366, and the MDR itself, including classification logic and the boundary between wellness software and a medical device (a boundary our product architecture is deliberately designed around).
• QMS design experience in a small or scaling company: you have built or substantially rebuilt a quality system, and you know the difference between a QMS that satisfies an auditor and one that also lets a ten-person team ship.
• Enough software fluency to be credible with engineers: you can read a CI pipeline, understand version control, and design controls that plug into how software is actually built. You do not need to code; you need to never be bluffed.
• Eligibility for the PRRC role under MDR Article 15 (so, a relevant degree plus regulatory/QMS experience, or the qualifying professional experience or demonstrated experience managing an outsourced PRRC arrangement).
• Direct audit-facing experience: you have hosted notified-body or certification audits and can prepare a team for one without theatre.
• The judgement to distinguish must-comply from gold-plating, and the communication skills to defend that line in both directions, both to auditors and to founders.
• AI/ML medical-device experience: MDCG guidance on AI, predetermined-change-control thinking, or EU AI Act implementation for a high-risk system.
• ISO 27001 or ISO 42001 implementation experience, or familiarity with integrating them into a 13485 management system.
• Clinical evaluation authorship (MEDDEV 2.7/1 rev 4 / MDCG guidance) for software devices, where the clinical evidence is literature-and-performance based.
• Gulf-region regulatory experience, especially with UAE health-authority pathways (federal or emirate-level), or with Saudi FDA/other GCC medical-device registrations. Given our 2027 UAE launch, this is the single strongest differentiator on this list.
• Post-market surveillance and vigilance system design for SaMD.
• Experience with regulated claims management for consumer-facing health products, including app-store review dynamics.

What We Offer

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