Software Engineer - Internal Regulatory Tooling

Foundation Partners; Cambridge; On-site; CAD 121,860 - 168,729; Full time

Benefits offered by this job

Onsite gym

EMI equity scheme

Medical coverage (dental and optical)

Remote work option on Wednesdays

Desk setup allowance

Monthly team feasts

Training budget

Job summary

Flok Health is seeking a QARA Engineer to take ownership of regulatory and quality assurance processes for medical device development. You will apply an engineering mindset to optimize procedures, design and implement tools, and support product engineers through V&V and risk management.

The role emphasizes cross-functional collaboration, usability studies, and building scalable processes in a fast-moving startup environment.

Qualifications

• ISO standards awareness (13485, 14971, 62304, 82304) and mapping to daily activities
• Design, implement and improve processes to meet regulatory requirements
• Collaborate with clinical, product and engineering teams to streamline workflows
• Build internal tools to support processes and regulatory work
• Support device technical file documentation, risk management, V&V activities

Responsibilities

• Know ISO standards applicable to Flok Health and how they map to day-to-day activities
• Help design, implement and improve processes for meeting requirements
• Collaborate with clinical, product and engineering teams to make processes efficient
• Build internal tools to improve processes
• Assist engineering with device technical file documentation, change process, risk management and V&V

Skills

Software engineering

QARA familiarity

Process design

Stakeholder collaboration

Job description

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

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.

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

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.

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!

A People team built for ambitious businesses

The old model for People & Talent doesn’t work for today's businesses. We've built a better one. Traditionally, early-stage Founders had two options: handle People & Talent themselves, losing precious time they should be spending on product or go-to-market, or hire a generalist, expected to cover everything from culture to recruitment to performance. We offer a more impactful alternative: A fully flexible, fractional People & Talent team with specialist skillsets and hands-on delivery, ready to start driving impact for your business in weeks, not months.