Artificial Intelligence (AI), Budgeting, Change Requests/Orders, Communication Skills, Detail Oriented, Documentation, External Audit, ISO (International Organization for Standardization), Internal Audit, Keyboards, Medical Equipment, Medical Treatment, Operational Support, Organizational Skills, Physical Therapy, Quality Management, Regulations, Regulatory Compliance, Risk Analysis, Time Management, Vendor/Supplier Evaluation
Regulatory Compliance Assistant
Engineering
Full-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.
Apply now
The Role
Flok Health has built the world's first AI physiotherapy clinic, working with the NHS and treating patients across the UK. Our patients get access to high-quality personalised care, without sitting on a waiting list or needing to leave their home. Part of our work involves building and maintaining a (Class IIa) software Medical Device, which includes an ISO 13485 compliant Quality Management System (QMS) in accordance with EU & UK regulations.
We're looking for a Compliance Assistant to help us in the day-to-day operation of our QMS. No prior experience of medical device development is required, as long as you're willing to learn. This is a varied role working across quality/regulatory, software, and operations, supporting multiple teams across the business, and you'll be working in an innovative regulated technical environment. You'll need:
- Strong organisational and time management skills
- Good communication skills with the ability to build effective working relationships
- And excellent attention to detail
Your key responsibilities will be:
- Supporting the administration and ongoing maintenance of the QMS
- Assisting colleagues with documenting and recording quality-related actions in line with agreed timelines
- Supporting periodic internal/external audits and reviews
- Supporting the tracking and reporting of QMS training across the organisation
- Running day-to-day regulatory affairs work, including change-request meetings, documenting supplier evaluations, facilitating risk analysis sessions, etc.
And the potential to develop into a QARA lead, helping us to improve our overall approach to regulatory compliance in multiple countries.
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!