Senior Quality & Regulatory Engineer - Medical Devices (Brain Therapeutics)

About us

We're a London-based neurotech startup developing non-invasive devices to treat brain disorders using ultrasound. We've developed a category defining technology platform, and we're now scaling our team to bring this technology to patients faster.

More than a billion people live with a brain disorder, and for many of them today's options are not good enough. Drugs work for some and fail others, often with serious side effects. Surgical treatments like deep brain stimulation are effective but invasive, and only available to a small fraction of those who could benefit. Non-invasive alternatives like TMS exist but can only reach the surface of the brain. Our platform makes it possible to focus ultrasound precisely on deep brain structures — non-invasively, safely, and repeatedly. We think that changes what's possible in brain therapeutics.

We build medical devices for people from every walk of life, and we believe our team should reflect the patients we serve. We strongly encourage applications from women, people from Black, Asian and minority ethnic backgrounds, and others underrepresented in medical technology. Different perspectives genuinely make our products better.

About the role

We're hiring a Quality & Regulatory Engineer to work alongside our engineering team and produce the documentation our device needs as it moves through development and submission: design controls, bench test protocols and reports, risk files, V&V packages, and the traceability that connects them.

This is our first dedicated quality and regulatory hire, a hands-on role where you'll be in the documents and the detail day to day, not directing from above. You'll work directly with the founders and engineering leads, with experienced external QA/RA consultants to lean on, and you'll shape how the quality function operates as we move through clinical studies and toward market.

What we're looking for

• Experience as a Quality Engineer, Design Assurance Engineer, or in a comparable embedded QA/RA role in medical devices — titles and seniority vary; what matters is the documentation you've produced and the standards you've worked against
• A degree in engineering, physics, or a related technical discipline

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• Hands-on experience producing the documentation that supports active medical device development — design controls, V&V protocols and reports, risk files, and the traceability between them
• Strong working knowledge of ISO 13485 design controls (§7.3) and ISO 14971
• Solid familiarity with IEC 60601-1 and -1-2 (electrical safety, EMC), IEC 62304 (software lifecycle), and IEC 62366-1 (usability)
• Awareness of ISO 10993 sufficient to scope biocompatibility testing
• Experience authoring bench test protocols and reports against harmonised standards
• Solid understanding of the UK and EU medical device regulatory landscape (UK MDR 2002, EU MDR 2017/745, MHRA processes)
• An appetite for an early-stage environment where you build rather than inherit

Bonus

• Experience preparing or supporting regulatory submissions (UK MDR / MHRA, EU MDR via notified body)
• Direct MHRA interaction experience
• FDA experience (Q-Sub, IDE, 510(k), De Novo)
• Experience supporting first-in-human studies of active medical devices
• ISO 13485 Lead Auditor certification

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• Familiarity with ultrasound devices or acoustic safety considerations (acoustic output, thermal index, mechanical index)

What you'll own

• Design controls per ISO 13485 §7.3, including the Design History File for our next-generation device
• Bench test protocols and reports against the relevant standards
• V&V documentation with traceability from requirements through risk controls to test evidence
• Risk management per ISO 14971
• The software lifecycle framework alongside engineering, per IEC 62304
• External testing programmes — biocompatibility, EMC, electrical safety
• SOPs and the QMS underpinning engineering work
• Regulatory liaison with the MHRA, notified bodies, and other agencies

Why join us

• Genuinely high-impact work: the documentation and processes you build go into a device intended to treat brain disorders
• Wide scope: design controls, V&V, risk, standards, and submissions — all under one role
• Our first dedicated QA/RA hire, with real ownership from day one
• Work closely with the founders, engineering leads, and external consultants
• A small, ambitious team that takes safety and rigour seriously

Compensation and working pattern

• £50–65k base salary, depending on experience
• Share options
• In-person role at our London office

We welcome applications from candidates requiring visa sponsorship. For successful candidates, we will cover the initial visa application fee and Immigration Health Surcharge for the main applicant.