Software Engineer - Internal Regulatory Tooling
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.
What We Offer
* Interesting and challenging work
* In‑person working from a beautiful work space in the Cambridgeshire countryside
* An onsite gym
* A digital health subscription of your choice
* Early stage equity with employee‑friendly terms (via an EMI scheme)
* Comprehensive medical coverage (including dental and optical) and life insurance
* Optional remote working on Wednesdays, with an annual allowance of 10 extra remote days
* Desk setup allowance for your favourite keyboard / mouse / whatever!
* Regular pulse‑checks to help us build a culture we’re proud of
* Monthly team BBQs and desserts on Flok
* A fast paced work environment geared towards excellence and professional growth (with annual training budget)
* Top notch specialty tea and coffee
* A chance to have a big impact in a small early stage team making a difference to the lives of people across the UK
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