Regulatory Systems Lead
SKILLS
FULL DESCRIPTION
Regulatory Systems Lead
[Employer hidden — sign up to reveal] is a digital-native healthcare provider. We are seeking a Regulatory Systems Lead to join our Engineering team in Cambridge (UK). This is a full-time hybrid role.
The Role
We are a software medical device manufacturer with 13458 certification and a Class IIa device on the market. We care deeply about quality and regulatory compliance. We're looking for someone to take ownership of maintaining and improving our regulatory systems. 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, 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).
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 [Employer hidden — sign up to reveal]
- 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!
If this sounds like something you'd enjoy, email [Employer hidden — sign up to reveal] with your CV & a cover letter, or apply via our contact form.