At a Glance
- Tasks: Lead regulatory systems to ensure compliance and improve processes in a dynamic healthcare environment.
- Company: Join a digital-native healthcare provider focused on patient-centred, scalable solutions.
- Benefits: Enjoy competitive pay, health coverage, gym access, and remote work options.
- Other info: Work in a beautiful countryside location with opportunities for professional growth.
- Why this job: Make a real impact in healthcare while growing your career in a supportive team.
- Qualifications: Experience in software medical device development and strong organisational skills required.
The predicted salary is between 60000 - 80000 £ per year.
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.
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 Role
We are a software medical 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 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 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!
Regulatory Systems Lead in Cambridge employer: Flok Health Ltd.
Contact Detail:
Flok Health Ltd. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Systems Lead in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend relevant events, and connect with potential colleagues on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their mission and values, especially how they relate to patient-centred care. This will help you tailor your responses and show that you're genuinely interested in being part of their team.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the role of Regulatory Systems Lead. Highlight your knowledge of software medical device development and your ability to design effective processes—this is your chance to shine!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re proactive and really want to be part of our innovative team at Flok.
We think you need these skills to ace Regulatory Systems Lead in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Systems Lead role. Highlight your experience with software medical devices and any relevant regulatory knowledge. We want to see how your skills align with our vision!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Share why you're passionate about patient-centred healthcare and how you can contribute to our mission. Keep it engaging and personal, just like our approach to treatment.
Showcase Your Process Design Skills: Since we care about quality and compliance, demonstrate your ability to design effective organisational processes. Share examples of how you've improved systems in the past—this will really catch our eye!
Apply Through Our Website: We encourage you to apply via our contact form on the website. It’s the easiest way for us to receive your application and ensures it gets into the right hands quickly. We can't wait to hear from you!
How to prepare for a job interview at Flok Health Ltd.
✨Know Your Regulations
Make sure you brush up on the latest med-dev regulations and guidelines. Being able to discuss how these impact the software development lifecycle will show that you're not just familiar with the rules, but that you can also apply them effectively.
✨Showcase Your Process Design Skills
Prepare examples of how you've designed and implemented organisational processes in the past. Be ready to discuss specific tools or methodologies you've used to streamline operations, as this will demonstrate your ability to enhance their systems.
✨Communicate Clearly
Since good communication is key for this role, practice articulating your thoughts clearly and concisely. Think about how you would explain complex regulatory concepts to non-experts, as this will highlight your collaboration skills.
✨Be Ready to Discuss Software Tools
Familiarise yourself with software tools that can aid in regulatory compliance and process management. If you've built any software before, be prepared to share your experiences and how they could relate to the internal tools they might need.