Quality & Regulatory Affairs Manager

Who We Are

At Heim,  we are reinventing how healthcare is accessed, and creating technology to make home the default place for care. 

We believe that healthcare is best delivered in the home of patients, and that we are at the cusp of a systemic shift away from hospital based care. 

We are creating the AI Native Operating System to power community health. Heim On-demand gives access to on-demand community nursing services to people who need them, and Heim Software is the AI-native OS platform that lets community organisations run their own services with the same level of efficiency, intelligence, and ease that we use ourselves. This role indexes heavily towards Heim Software and is responsible for ensuring our technology is at the forefront of regulation for AISaMD and other relevant accreditations. 

We are CQC registered and ISO 27001 accredited. We are already on our journey to class I MDR and aim to have this filed in the coming months. Our next step is MDR II.

The Role

We are hiring our first Quality & Regulatory Affairs Manager to own how Heim builds safe, compliant and trusted products. Heim Software is moving to UKCA Class I and then Class II as our AI capabilities grow from operational to increasingly clinical decision support and automation. 

You will own our quality management system, our regulatory route to market, and the information governance every NHS partner needs before go-live. You will act as Heim's Quality Manager and Data Protection Officer. You will bring this work in-house from our current external support and build a function that lets us ship fast and stay safe.

You are accountable for three outcomes:

1. Market access on plan. Class I UKCA in place, then Class II, on a timeline the business can plan around.

2. Governance that never blocks a deal. DPIAs, DTAC, DSPT and ISO 27001 evidence ready for every trust, so governance speeds up go-live.

3. A quality system that keeps pace. An audit-ready QMS built for a fast-moving AI product, with post-market evidence that proves it is safe and performs.

What You'll Do

MDR Certification & Regulatory Delivery

• Define regulatory strategy for Heim’s upcoming MDR filings (Classification, intended use, claims) 

• Act as Quality Manager: own and run our ISO 13485 quality management system

• Own risk management (ISO 14971), the software lifecycle (IEC 62304) and usability (IEC 62366) with Product and Engineering

• Own the development of the technical documentation for our upcoming Class I and Class II devices including:

  • Clinical Evaluation (CEP / CER)

  • Risk Management File (ISO 14971 aligned)

  • Software lifecycle documentation (as applicable) 

• Own the UKCA registration and approved body process for Class II 

• Design and run post-market surveillance and post-market validation studies, working with our clinical and data teams

• Set up change control for AI features, so model updates move quickly without breaking our regulatory position

• Advise on regulatory routes for new markets, including the US
  

Own information governance

• Act as Heim's Data Protection Officer, advising leadership independently on UK GDPR compliance

• Support DPIAs and data flow sign-off in commercial conversations and NHS go-lives, advising partners and our commercial team

• Own DTAC and DSPT submissions

• Maintain our ISO 27001 certification and lead recertification and surveillance audits

Clinical safety (desirable)

• Run the DCB0129 clinical safety process: hazard logs, safety cases and release sign-off, as Clinical Safety Officer if you hold the credentials

Build the function, with AI at the core

• Work in an AI-native manner to make quality and regulatory work faster: documentation, evidence, audit preparation

• Make compliance easy for the team, with clear processes that fit how a startup actually works. We need the team delivering on our regulatory requirements as part of our day to day and not seen as an afterthought. You’ll therefore need to build an everyday awareness of this into the culture and fabric of the team.