The Role

We 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

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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, Scarlet Comply
• In future, line managing other QARA roles

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

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What We Offer

• Challenging work at the frontier of AI-native healthcare
• In-person collaborative culture in a beautiful work space in the Cambridgeshire countryside
• An onsite gym and 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!
• Monthly team feasts (and the BBQ is used most days)
• A fast paced work environment geared towards excellence and professional growth (with annual training budget)
• A chance to have a big impact in a small team transforming care and outcomes at population scale
  

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About Flok

More than a billion people a year suffer unnecessarily from conditions like MSK pain, where the right treatment approach is well-established but undeliverable at scale. We're changing that. Our team has deep expertise across clinical, engineering, and regulated AI, has a track record of healthtech innovation, and is backed by top VCs and multiple unicorn founder angels.

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If you like:

• Solving hard problems at the intersection of technology and healthcare
• The pursuit of excellence—helping each other to do the best work of our careers
• Working in an in-person collaborative environment
• Taking ownership to have significant impact in a fast-growing mission-driven company with big ambitions

Then you'll fit right in!