SISU Health UK
Regulatory Affairs Specialist (Medical Devices & Digital Health)
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12-Month fixed term | Full or part-time | Remote (UK)
At SISU Health, we are on a mission to make preventative healthcare more accessible and impactful. Our SISU Health Stations bring self-service health checks into workplaces, pharmacies, community settings and public spaces, helping people understand their health in minutes.
The SISU Health platform combines a medical device with digital health technology, personalised health insights and referral pathways to identify people at risk of conditions such as hypertension, cardiovascular disease and diabetes.
The Role
We're looking for an experienced, pragmatic Regulatory Affairs Specialist to join us on an initial 12-month contract. You will play a central role in shaping and delivering the regulatory strategy for our connected health platform and next generation of products.
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Your primary focus will be leading the execution of the regulatory strategy for the SiSU Health platform, including:
- New product registration (ClassI and Class11a).
- Preparing, reviewing and maintaining technical documentation and regulatory submissions.
- Assessing regulatory impact of new product features and design changes.
- ISO13485 Quality Management System activities and external audits.
- Providing practical regulatory advice, monitoring regulatory developments and responding to regulatory compliance enquiries.
About You
- Has 5+ years' experience in Regulatory Affairs within medical devices or digital health.
- Has practical experience with MDR, MHRA and ideally Class I and Class IIa software-enabled or connected medical devices.
- Has experience with ISO13485
- Can confidently write and review technical documentation and regulatory submissions.
- Enjoy working independently in scale-up environments, being hands-on and making decisions quickly.
- Enjoys solving problems and finding pragmatic, balanced solutions
- Enjoys collaborating closely with Teams across the business
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Why SISU Health
You'll be joining a growing health technology company where your work directly influences improving the health of thousands of people every year.
If you're looking for a role where you can combine regulatory expertise with execution, innovation, collaboration and real impact, we'd love to hear from you.
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