Chief QA & Regulatory Lead for AI SaMD

Reset Health; Greater London; On-site; GBP 80,000 - 90,000; Full time

Benefits offered by this job

Competitive salary £80,000-£90,000 per

Private medical insurance

Enhanced parental leave

Enhanced sick leave

Pension scheme

Job summary

Reset Health, the Therapeutic Optimisation Company, seeks a Head of Quality Assurance and Regulatory Affairs to own the regulatory strategy and build our quality function. You’ll run the QMS day to day, lead audits, and steer the path to market for AI‑driven SaMD products.

You’ll be the first dedicated QARA hire, shaping quality and regulatory affairs at a fast-growing health tech company, with responsibilities spanning regulatory routes, ISO compliance, and collaboration across teams to ensure

Qualifications

• Track record leading SaMD through regulatory approval and ISO 13485 certification.
• Strong ISO 13485 and IEC 62304 expertise with regulatory strategy experience.
• Hands-on approach with attention to detail.
• Ability to build trusted cross-functional relationships including Notified Bodies.
• Eligibility to act as PRRC under EU MDR.

Responsibilities

• Own our regulatory strategy and routes to market via EU MDR and FDA.
• Act as PRRC and main contact for Notified Bodies and health authorities.
• Maintain ISO compliance across the QMS, partner with Governance Lead, and lead the move to an eQMS when needed.
• Embed ISO 13485, IEC 62304 and ISO 14971 into the product lifecycle with Product, Engineering and Clinical teams.
• Lead preparation for certification and surveillance audits.
• Run day-to-day quality: Technical Files, DHF, post-market surveillance, CAPA, supplier and risk management.

Skills

Quality leadership

Regulatory affairs

ISO 13485

IEC 62304

PRRC eligibility

Audit leadership

Stakeholder management

QMS management

Job description

Reset Health, the Therapeutic Optimisation Company, seeks a Head of Quality Assurance and Regulatory Affairs to own the regulatory strategy and build our quality function. You’ll run the QMS day to day, lead audits, and steer the path to market for AI‑driven SaMD products.

You’ll be the first dedicated QARA hire, shaping quality and regulatory affairs at a fast-growing health tech company, with responsibilities spanning regulatory routes, ISO compliance, and collaboration across teams to ensure