Who are we?

MiMIAT Health has developed a patient-controlled longitudinal health record that makes disease evolution visible and enables data continuity across fragmented care settings for multidisciplinary teams managing hard-to-diagnose diseases.

Our work has been recognised through PRECISEU Best Practice Recognition, AstraZeneca ACCIÓN, Google for Startups for Sustainable Development and NVIDIA Inception. We are also part of COST Action CA24114, focused on blood, tissues and cells as starting materials for advanced therapies.

MiMIAT is now developing Mimi, a multilingual voice AI layer built on top of its patient-controlled longitudinal health record. Mimi is intended to continuously reconstruct and interpret each patient’s disease trajectory across clinical records, biomarkers, medication history, treatment response, patient-reported data, connected devices and family history.

Mimi will identify missing context, contradictions and changes that the current diagnosis or treatment may no longer explain, transforming fragmented information into structured, reviewable clinical intelligence for patients and multidisciplinary care teams.

What are we looking for?

We’re looking for a Regulatory Affairs & Compliance Lead to help strengthen MiMIAT’s regulatory and compliance foundations as our product, partnerships and healthcare deployments continue evolving.

Given our current stage, this is an initial pro bono/volunteer collaboration with a light commitment of approximately 1–2 hours per week, designed for an experienced professional who can bring strong regulatory judgement without requiring a large weekly commitment.

You’ll join a growing multidisciplinary team spanning health, science, technology and behavioural design, contributing regulatory expertise at a stage where key product and strategic decisions are still being shaped.

As MiMIAT enters its next product stage, this role will help shape our transition from a non-medical-device digital health platform toward a regulated Medical Device Software pathway, with Class IIa currently forming part of our intended regulatory direction. The Lead will help define the intended purpose, regulatory strategy, evidence and quality foundations required for that evolution, while ensuring that new AI-enabled and clinician-facing capabilities are developed within the appropriate regulatory framework.

What you’ll do

• Help define and maintain MiMIAT’s regulatory positioning as the product evolves.
• Assess product features, intended use, claims and workflows from a digital-health regulatory perspective.
• Support regulatory questions around Medical Device Software and MDR-related boundaries where relevant.
• Help us navigate considerations related to GDPR, health data governance, EHDS and the evolving European regulatory environment for AI.
• Review and help structure privacy, consent and compliance-facing documentation, coordinating with specialist legal counsel where required.
• Assess practical regulatory risks related to patient data flows, clinician-facing functionality, AI-enabled features and healthcare deployments.
• Support preparation for pilots and conversations with hospitals, clinics, public healthcare organisations and other institutional stakeholders.
• Help establish a pragmatic regulatory roadmap, distinguishing what MiMIAT should put in place now from what will become necessary as the product and company mature.
• Identify questions that require deeper external specialist review and help structure them clearly for escalation.

Who are you?

• You have 4+ years of direct professional experience in regulatory affairs, compliance, quality, privacy or healthcare law within digital health, MedTech or medical devices. Healthcare-specific experience is essential for this role.
• You have hands-on experience supporting at least one digital health or medical software product through regulatory strategy, classification, quality/evidence planning, or preparation for a Medical Device Software pathway.
• You have strong familiarity with GDPR and the European digital-health regulatory landscape.
• You understand regulatory questions around areas such as Medical Device Software, MDR, intended purpose, product claims, health data governance or clinical software.
• You can translate regulatory requirements into practical recommendations for product, technical, clinical and operational teams.
• You are comfortable working in an early-stage environment where regulatory strategy needs to evolve alongside the product.
• You bring strong judgement and know when an issue can be addressed internally and when specialist legal, clinical, privacy, cybersecurity or regulatory expertise should be involved.
• Familiarity with areas such as the EU AI Act, EHDS, Quality Management Systems, ISO 13485, ISO 14971, IEC 62304, ISO/IEC 27001, or hospital and public-health deployment environments would be highly valuable.
• You can commit approximately 1–2 hours per week and are excited by the opportunity to contribute at a foundational stage.

Benefits

• Contribute with a deliberately light commitment of approximately 1–2 hours per week, designed to fit alongside an experienced professional’s existing work.
• Help shape MiMIAT’s regulatory transition toward a Medical Device Software pathway, with a potential Class IIa direction, from an early stage.
• Work on real regulatory decisions around intended purpose, claims, AI-enabled functionality, health data, evidence requirements and healthcare deployment.
• Gain direct exposure to hospital, public-health and institutional collaborations, rather than hypothetical case studies.
• Join a multidisciplinary HealthTech team entering a new stage of product, clinical and organisational maturity.
• Build experience at the intersection of MDR, AI regulation, EHDS, GDPR and patient-facing digital health.
• Join a company recognised as a PRECISEU Best Practice, supported through AstraZeneca ACCIÓN, Google for Startups for Sustainable Development, NVIDIA Inception and ESADE eWorks, and increasingly involved in EU-level healthcare and research conversations through COST Action CA24114.
• As MiMIAT evolves, the structure and scope of the role will be reviewed at each stage, without any commitment regarding future employment, compensation or equity at this stage.

How to apply

Send your CV to info@mimiathealth.com or reach out directly here on LinkedIn.

Please include a short note outlining your healthcare or digital-health regulatory experience and why MiMIAT Health interests you.

If this speaks to you, we’d love to hear from you!