QA & Regulatory Affairs Lead for SaMD & QMS Strategy

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

Benefits offered by this job

Private medical insurance

Enhanced parental leave

Enhanced sick leave

Pension scheme

Career growth opportunities

Job summary

Reset Health Limited is seeking a Head of Quality Assurance and Regulatory Affairs (QARA) to own our regulatory strategy and build the quality function. You’ll lead QMS operations, audits, and set the route to market for our AI-driven SaMD products, with a hands-on approach and a focus on patient safety.

You’ll be the first dedicated QARA hire, reporting into senior leadership, shaping ISO 13485 implementation, and coordinating with Notified Bodies as we scale in a fast-growing health tech

Qualifications

• Track record leading digital health or SaMD through regulatory approval and ISO 13485 certification.
• Strong expertise in ISO 13485 and IEC 62304; experience setting regulatory strategy.
• Hands-on approach with attention to detail.
• Ability to build relationships with senior colleagues and 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, lead move to an eQMS when needed.
• Embed ISO 13485, IEC 62304 and ISO 14971 into the product lifecycle with cross-functional teams.
• Lead preparation for certification and surveillance audits.
• Run day-to-day quality activities: Technical Files, DHF, post-market surveillance, CAPA, supplier and risk management.

Skills

Regulatory strategy

ISO 13485

IEC 62304

PRRC eligibility

QMS management

Audits

Notified Bodies liaison

Risk management

DHF/Technical Files

Product lifecycle focus

Job description

Reset Health Limited is seeking a Head of Quality Assurance and Regulatory Affairs (QARA) to own our regulatory strategy and build the quality function. You’ll lead QMS operations, audits, and set the route to market for our AI-driven SaMD products, with a hands-on approach and a focus on patient safety.

You’ll be the first dedicated QARA hire, reporting into senior leadership, shaping ISO 13485 implementation, and coordinating with Notified Bodies as we scale in a fast-growing health tech