Software Engineer, Internal Regulatory Tooling

Foundation Partners are embedded, and work as part of their internal team, at Flok Health.

You can view this job directly on Flok Health's career page here

This role is required in-office 4 days a week in our office near Cambridge, United Kingdom.

The Role

We're looking for someone with a software engineering background to take significant responsibility in developing tools and processes for our quality and regulatory function, helping us to build high quality medical devices.

You’d be the first dedicated QARA Engineer at Flok, and as such would have influence and ownership in the role. We think of the role as an application of an engineering approach to the optimisation of our processes, specifically to meet the requirements of medical device development standards. You'd be building tools and processes to support our product engineers so the role requires a keen user-centric mindset and ability to work with people across the business.

You’d be responsible for:

• Knowing the ISO standards applicable to us (13485, 14971, 62304, 82304 in particular) and understanding how they map onto day-to-day Flok activities and tools

• Helping us design, implement and improve processes for meeting the requirements

• Working closely with the teams involved in each process (particularly clinical, product and engineering) to make the processes more efficient and easier to run: spotting opportunities to eliminate friction, bottlenecks, and unnecessary overhead or work

• Building internal tools where possible to improve processes

• Helping the engineering team to ensure our device(s) technical file documentation is complete, particularly around the change process, risk management, requirements capture and V&V

And potentially other activities related to QARA, including designing and running usability studies for our device(s).

You don't need to have many years of experience in a role just like this, but we are looking for exposure to software-as-medical-device development and a desire to learn more.

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