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About the Role

This is a foundational role at the intersection of innovation, safety and trust, critical to enabling the safe deployment of AI in paediatric care at scale. You will shape and lead the company's end-to-end regulatory, quality management, and governance strategy from first principles, ensuring the platform aligns with UK and international regulatory frameworks and embeds best-in-class standards in data protection, clinical safety, quality management systems, and information governance.

Responsibilities

Work closely with the founding team to define the regulatory pathway for our first use cases, starting with fracture diagnostics, including classification, evidence strategy and regulator engagement.
Bring experience in CE marking and FDA regulatory pathways to enable international scale, designing frameworks for compliant deployment across multiple jurisdictions.
Lead the development and negotiation of robust data governance frameworks, including complex data sharing agreements with NHS organisations and other healthcare partners.

Requirements

10+ years in regulatory, data protection, clinical safety or compliance roles within healthcare, medtech or digital health.
Demonstrable experience navigating UK/EU regulatory frameworks (e.g. MHRA, UKCA/CE marking, GDPR).
FDA regulatory pathway experience strongly preferred.
Expertise in successfully gaining Class IIb accreditations, or similar, for software/AI as a medical device.
Proven track record establishing and negotiating data sharing agreements within healthcare environments (e.g. NHS or equivalent systems).
Ability to translate complex regulatory requirements into practical product and engineering decisions.
Deep understanding of data governance, quality management systems, patient privacy and ethical AI in high-stakes clinical settings.
Experience shaping regulatory strategy and end-to-end delivery across multiple jurisdictions (UK, EU, US), with deep expertise in CE marking and FDA approval processes.
Expertise structuring and executing data sharing agreements and information governance frameworks.
Strong judgement, able to balance innovation with safety and compliance.
Comfort operating in an early-stage, high-ownership environment.

Skills

Regulatory affairs
Data protection
Clinical safety
GDPR
ISO 13485
DCB0129/0160
CE marking
FDA regulatory pathways
Data governance
Quality management systems
Information governance
UKCA marking

Location

Work Type

Full-time

Experience Level

10+ years

Education Level

Degree in Law, Medicine, Life Sciences, Health Policy or a related field
Relevant professional qualifications or certifications in regulatory affairs, data protection or clinical safety (e.g. GDPR, ISO 13485, DCB0129/0160) strongly preferred

About the Company

Stealth-mode health AI company, backed by a Tier 1 venture capital firm, on a mission to transform paediatric diagnosis through next-generation multimodal AI.
Ambition isn’t incremental improvement, it’s to fundamentally shift how paediatric radiology is delivered, validated and scaled in real-world clinical environments.