Head of QA/RA

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 are looking for a Head of Quality Assurance and Regulatory Affairs (QARA) to own our regulatory strategy and build our quality function.

Reset Health is the Therapeutic Optimisation Company. The future of healthcare is not just about creating better medicines. It is about achieving the best possible outcome from every medicine, for every patient.

You’ll be our first dedicated QARA hire, with the chance to shape quality and regulatory affairs at a fast-growing health tech company. You’ll run the Quality Management System (QMS) day to day, provide hands‑on leadership through audits, and ensure our path to market is clear, sustainable and grounded in patient safety. Your first big milestones will be taking full ownership of our regulatory work and setting a clear route to market for our AI‑driven Software as a Medical Device (SaMD) products.

Roles & Responsibilities

• Own our regulatory strategy and routes to market via EU MDR and FDA.
• Act as our PRRC and main contact for Notified Bodies and health authorities.
• Maintain ISO compliance across our QMS, partnering with our 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.

Essential

• A track record of leading digital health or SaMD products through regulatory approval and ISO 13485 certification.
• Strong technical expertise in ISO 13485 and IEC 62304, and experience setting regulatory strategy.
• A hands‑on approach and a love of getting into the detail.
• The ability to build trusted relationships with senior colleagues across functions and with Notified Bodies.
• Eligibility to act as PRRC under EU MDR requirements.

Desirable

• Experience leading AI as a Medical Device (AIaMD) products through regulatory approval.
• Experience using AI tools to speed up development and documentation.
• Experience leading organisational change, including implementing an eQMS, while keeping product delivery on track.
• Experience moving teams from an external regulatory consultancy model to in‑house operational ownership.

If you meet most of the requirements but not all, we’d still encourage you to apply. Great QA/RA professionals come from many different backgrounds and career paths, and we want our team to reflect that. If you need any adjustments during the application process, just let us know.

What we offer

• Competitive salary of £80,000-£90,000 per annum, depending on experience
• Opportunities to build skills and progress within a growing digital health organisation
• Private medical insurance
• Enhanced parental leave
• Enhanced sick leave
• Pension scheme