Quality and Regulatory Affairs Specialist (Software/SaMD)

Are you interested in accelerating the fight against dementia? Join our team at Prodromic to translate AI-powered solutions for early dementia prediction to healthcare. About us Prodromic is a Cambridge-based AI health technology spin-out dedicated to transforming brain health through responsible multimodal AI. Our platform, Sia, provides early personalised predictions of dementia progression and helps stratify patients using cognitive assessments, imaging, blood-based biomarkers, genetics, proteomics, and health records. Drawing on over a decade of groundbreaking research, we convert complex biological data into clear, clinically useful insights. These insights help accelerate clinical trials, reduce costs, and deliver better outcomes for patients in everyday care. We are currently advancing Sia from a well-validated research prototype to a fully regulated medical software device. This is a great opportunity to join our dynamic, growing, and highly driven team and contribute directly to the fight against dementia by accelerating the development of our AI powered-solution for NHS adoption and wider deployment.

About the role

As Quality and Regulatory Affairs Specialist you will own the day-to-day quality and regulatory work that takes Sia (Software as a Medical Device) through to UKCA marking and NHS deployment. You will build and run our quality management system, maintain the regulatory documentation and technical file, and make sure our development, validation, and clinical evidence activities meet IEC 62304, ISO 13485, and ISO 14971.

You will work closely with all our team including software engineer, AI scientist, platform integration specialist, clinicians, and regulatory advisors, translating regulatory requirements into clear, workable processes the team can actually follow. This is a hands-on, standalone role with consultant support available that suits someone who wants ownership of a regulatory programme and is comfortable being the person who keeps it on track.

What you will do

Set up, maintain, and continuously improve our ISO 13485 quality management system.
Own and maintain the regulatory documentation and technical file for Sia, keeping it submission-ready against the MHRA UKCA SaMD pathway.
Lead risk management activities to ISO 14971, including the risk management file, hazard analysis, and AI/ML-specific risk considerations.
Make sure software lifecycle activities meet IEC 62304, working with engineering to embed quality into development, verification, and validation rather than bolting it on afterwards.
Draft, control, and keep current our standard operating procedures, work instructions, and records, and make sure procedures are operationally in place before they are cited in live documents.
Support DTAC, DCB0129, and information governance readiness, and contribute to ISO 27001 and Cyber Essentials Plus activities.
Coordinate verification and validation documentation, traceability, and design history, drawing evidence together from across the work packages.
Prepare for and support internal and external audits, and act as the practical point of contact for quality and regulatory queries across the team.
Work alongside our regulatory advisors, taking strategic direction and turning it into delivery on the ground.
Engage with external partners, suppliers, and notified body or assessment contacts on quality and regulatory matters.

Essential requirements

Degree in a relevant scientific, engineering, life sciences, or regulatory discipline, or equivalent practical experience.
3–5 years of practical quality and regulatory affairs experience in medical devices, with clear hands-on involvement in software medical devices (SaMD) or digital health.
Working knowledge of IEC 62304, ISO 13485, and ISO 14971, and the ability to apply them to a real development programme rather than describe them in the abstract.
Experience building or maintaining a quality management system and its core processes, ideally within an eQMS.
Experience preparing and maintaining technical documentation and technical files for regulatory submission.
Ability to work independently, take ownership of a regulatory programme, and keep it moving in a dynamic start-up environment.
Strong written and spoken communication skills, and the ability to translate regulatory requirements into clear processes for a technical team.

Desirable requirements

Familiarity with the MHRA UKCA SaMD pathway and the evolving UK regulatory landscape for AI as a medical device.
Experience with NHS-specific frameworks such as DTAC, DCB0129, and information governance, and with ISO 27001 or Cyber Essentials Plus.
Exposure to AI/ML-based devices and the particular risk, validation, and lifecycle considerations they raise.
Experience supporting audits or working with a notified body or UK approved body.
Understanding of NHS data infrastructure and secure data environments.

How to Apply

We are looking for someone to join the team as soon as possible and will be reviewing applications on a rolling basis. If this sounds like you;

Send your CV and cover letter to [email protected] referencing job reference PR062603 or reach out for a confidential conversation at [email protected]. Applicants must have the right to work in the UK.