Our vision is a new category of habit-forming healthcare globally; one that is patient-centred, predictive, and intrinsically scalable. We're a digital-native healthcare provider, using personalised video streams to deliver treatment pathways at population scale, with transformative economics. By personalising each patient's interaction in real-time, we deliver world-class medical treatment in an engaging consumer experience.Regulatory Systems LeadEngineeringFull-time, Cambridge (UK)If this sounds like something you'd enjoy, email join@flok.health with your CV & a cover letter, or apply via our contact form.### The RoleWe are a software medical device device manufacturer, with 13458 certification and a Class IIa device on the market. We care deeply about making quality and regulatory compliance a first class citizen, not an afterthought. We think "doing regulatory" well is a strong competitive advantage, and we have built internal systems, including processes and custom internal tools, to help us do so.We’re now looking for someone to take ownership of maintaining and improving those systems, supporting us as we grow our team and commercial reach. You’ll need:* Prior knowledge/experience of the software medical device development lifecycle* Strong ability to design and build good organisational processes and systems* A good sense of how software tooling can remove friction and accelerate processes. Even better if you have built software in the past.* Good communication and cross-function collaboration skills**You’d be responsible for:*** Understanding the relevant med-dev regulation and keeping up to date with changes, guidances etc.* Designing compliant processes for us (including helping the CTO/Engineering Director to design the software development process, CAPAs, feedback, etc)* Training the relevant teams on those SOPs* Facilitating risk analysis sessions and maintaining the Risk Management Report* Acting as Product Manager for internal regulatory tools—helping us to decide what to build, and, possibly, participating in building them.* Running audits (internal 13485 & external)* Being the key point of contact for our Notified Body,* In future, line managing other QARA rolesAnd potentially other activities related to QARA, including designing and running usability studies for our device(s).### 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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