Head of Regulatory Affairs

Head of Regulatory Affairs – AI & Digital Health

Remote-first | UK headquarters | International travel

Are you an experienced regulatory affairs leader with a background in Software as a Medical Device (SaMD), digital health or AI-enabled medical technologies?

Zest Scientific is proud to be partnering with an ambitious, high-growth digital health organisation developing evidence-based health programmes and next-generation AI-enabled healthcare products.

Combining behavioural science, clinical expertise, technology and user-centred design, the business develops digital health programmes for international non-profit organisations, with ambitious plans to expand into AI-enabled medical devices and higher-class regulated software across the UK and US markets.

This is a unique opportunity to shape regulatory strategy at an early stage, building a scalable quality framework that supports innovation, patient safety and international market access. Reporting directly to the CEO, you will play a pivotal role in ensuring regulation is embedded into product development and business strategy from day one.

The Candidate

You are an experienced regulatory affairs professional with a strong track record in medical-device software, digital health or a closely related regulated technology environment.

• You have led regulatory strategy for software-based medical devices, ideally across both the UK and US markets.
• You have experience with UK Class IIa/IIb and US Class II regulatory pathways, including relevant submissions and market-access activities.
• You possess strong working knowledge of ISO 13485, ISO 14971 and IEC 62304, alongside medical-device quality management and software development controls.
• You have experience developing and maintaining technical documentation, risk management files, clinical evidence and design history records.
• You understand the regulatory challenges associated with AI/ML-enabled medical devices, including algorithm validation, model changes, clinical evidence and post-market monitoring.
• You are confident leading audits, managing CAPAs, working with regulatory bodies and strengthening quality management systems.
• You thrive in a cross-functional environment, partnering with Product, Clinical and Technology teams to embed regulatory requirements throughout product development.
• You combine strategic thinking with a hands-on approach, comfortable setting the long-term regulatory direction while resolving practical quality and compliance challenges.
• You communicate complex regulatory requirements clearly, providing pragmatic advice and constructive challenge to senior leadership.

The Role

As Head of Regulatory Affairs, you will own the organisation's regulatory strategy and the integrity of its software medical-device portfolio, helping the business transition from its current regulatory foundations towards more sophisticated, internationally regulated products.

Your responsibilities will include:

• Regulatory strategy: Define and deliver the UK and US regulatory roadmap, including product classification, intended purpose, claims and routes to market.
• Quality management: Lead and develop the ISO 13485 quality management system, ensuring it is practical, scalable and embedded in day-to-day operations.
• Class II readiness: Establish the regulatory, technical and evidence requirements needed to support future higher-class medical-device products.
• AI and SaMD governance: Develop proportionate regulatory frameworks for AI-enabled products, covering validation, risk management, algorithm changes and ongoing monitoring.
• Technical documentation and evidence: Ensure product documentation, clinical evaluation, risk files and software development records meet applicable regulatory requirements.
• Audits and compliance: Oversee internal audits, external certification activities, CAPAs, regulatory registrations and post-market surveillance.
• Cross-functional leadership: Work closely with the CEO, CTO, CPO and Chief Medical Officer to ensure regulatory considerations inform product discovery, design, development and release.
• External relationships: Manage relationships with regulatory advisers, UK Approved Bodies and relevant US regulatory partners.
• Executive advisory: Provide clear advice on regulatory risks, product readiness, market access, investment priorities and the decisions required to support sustainable growth.

This is a strategic leadership role with a meaningful hands-on component. You will build the systems, processes and regulatory capability that enable the organisation to innovate responsibly and scale with confidence.

The Company

Our client is an ambitious digital health organisation focused on helping people live healthier lives through evidence-based programmes that can be delivered at scale.

Its work combines behavioural science, clinical expertise, technology and user-centred design to deliver digital health programmes for international non-profit organisations, while building towards a new generation of AI-enabled medical technologies.

The business is entering an exciting phase of development, strengthening its regulatory foundations, progressing towards higher-class medical-device capability, expanding internationally and embedding AI across both its products and operating model.

You will join a lean, experienced team working alongside senior leaders in technology, clinical medicine, product and business operations, with the opportunity to shape how a growing digital health organisation develops and delivers regulated products.

Remuneration and Benefits

Our client is committed to securing the services of the right candidate and offers a competitive package aligned with experience and market expectations.

The package includes:

• Competitive compensation.
• An equity stake.
• Flexible, remote-first working.
• Annual learning and professional-development budget.
• Access to leading regulatory, quality and AI tools.
• Opportunities to attend international conferences and industry events.
• Private healthcare, where applicable.
• Pension or equivalent retirement contributions.
• Generous annual leave and wellbeing days.