About the company

Neuronostics is a multi-award-winning medical technology company, spun out of the University of Exeter in 2018. Since then, we’ve been supported by research grants and private equity of more than £5M, enabling us to rapidly grow our team as we seek to accelerate our route to market.

Our mission is simple: to revolutionise diagnosis and treatment of neurological conditions. We achieve this through the development of digital biomarkers that can be measured from data that is routinely collected clinically. Our current focus is on epilepsy: a serious brain disorder that affects over 600,000 people in the UK alone. We have developed the first digital biomarker of epilepsy (BioEP) that can reveal the risk of future seizures from routinely acquired measurements of the brain’s electrical activity (EEG). BioEP as Software as a Medical Device (SaMD) will be used by healthcare professionals to assist the diagnosis and prognosis of epilepsy, to ultimately improve the treatment and care pathway for those living with epilepsy or suspected epilepsy.

We are conveniently located in the Engine Shed by Bristol Temple Meads Station, we are part of the internationally recognised SETsquared incubator. This provides access to experts in the fields of business, marketing, technology and legal who act as mentors. It’s an exciting ecosystem of other start-ups to work within, all learning from and supporting each other on the road to success.

About the role

As the Quality and Compliance Manager, reporting to the Head of Regulatory Affairs, you will understand the quality and compliance standards which must be met for our key market access (UK/EU/US).

You will have experience in running or supporting the maintenance/preparation of the documentation required for EU MDR, FDA guidelines, ISO 13485, & ISO 27001.

As we are developing Software as a Medical Device (SaMD) healthcare products, you will need to be aware of the working practices/tools used when developing software and be comfortable working closely with technical staff.

You will be someone who enjoys working in a start-up environment, is happy to learn on the job and adapt your approach as new opportunities emerge, and lead from the front as required in a rapidly growing team.

In this role you will:

• Own the day to day running of our Quality Management System, which is certified to ISO 13485.
• Demonstrate continuous improvement in the QMS, by regularly reviewing processes and policies, streamlining or expanding where required.
• Maintain our QMS processes, report on QMS performance to the Head of Regulatory Affairs.
• Conduct Internal audits for ISO 13485.
• Prepare Management Review documentation for ISO 13485.
• Support the Head of Regulatory Affairs and Science team in preparing post-market surveillance reports.
• Work with the technical team to submit our annual NHS DPS Toolkit submission and Cyber Essentials.
• A key project during 2025 will be to implement and achieve certification in ISO 27001 across the company, helping to foster a deep understanding of its importance. There will be support from the technical team and operations team to achieve this.
• Support the Head of Regulatory Affairs in submitting regulatory approvals, namely helping with document preparation and conducting research and analysis of regulatory requirements and policies for markets (usually the US, the UK, and the EU) that the company is looking to enter with existing and future products.
• Support the Head of Regulatory Affairs and Product Owner to comply with IEC 62304 when generating technical documentation for our products, namely helping compile release reports, and reviewing technical documentation for compliance.
• Support the Head of Regulatory Affairs in external audits especially ISO 13485 Audits, by preparing required documents, briefing wider team on what to expect, evidencing requested records by the auditor.

About you

• Experience in MedTech products, ideally Software As a Medical Device and/or AI powered solutions.
• Experience in supporting with approvals and successful external audits from bodies including FDA / EU MDR / UK CA / CDMR / ISO 13485.
• Experience developing and maintaining a Quality Management System (QMS).
• Experience in supporting meeting NHS standards in clinical risk management – DCB0129/0160.
• Keen eye for detail and exceptional presentation skills.
• Where possible, experience with ISO 27001 or some level of Information Security standards (NHS DSP Toolkit, GDPR etc).
• Trained to ISO 13485 internal auditor standard (we can provide training if you are not currently).

Research indicates that certain demographics, such as women, may be hesitant to apply for a position unless they fulfil all the job criteria. Regardless of your background, we urge you to consider applying for any of our open positions, as you could very well be the ideal candidate we are seeking.

What we can offer

• Salary £40,000 – £45,000 dependent on experience.
• Access to ongoing professional development including training relevant to the role.
• A dynamic and collaborative environment, where curiosity and innovation are encouraged.
• Neuronostics operates a hybrid working environment blending time in the office (our Bristol HQ – situated right outside Bristol Temple Meads) with working from home.
• 20 days annual leave (pro-rata), plus public/bank holidays. Staff members also receive an additional day off to celebrate their birthday and receive an additional days leave for each full year of service, up to a maximum of 25 days annual leave (pro rata). Staff members may also purchase additional leave up to a maximum of 25 days annual leave (pro rata).
• Team socials.
• Company Salary Sacrifice Pension Scheme (you contribute 2% and the company 7% on qualifying earnings).

How to apply

Applicants are encouraged to get in touch early for an informal chat about the role so please email recruitment@neuronostics.com if you are interested in applying.

To apply, an application consisting of a CV and accompanying cover letter outlining how your skills, experience and future career plans align with what we are looking for should be emailed to us.

Applications will be considered on a rolling basis until the position is filled.

We look forward to hearing from you.