At a Glance
- Tasks: Lead regulatory strategy for innovative health tech products and ensure compliance.
- Company: Join SISU Health, a pioneering company in preventative healthcare.
- Benefits: Flexible working hours, remote options, and the chance to make a real impact.
- Other info: Dynamic scale-up environment with opportunities for personal and professional growth.
- Why this job: Shape the future of health technology while improving lives across the UK.
- Qualifications: 5+ years in Regulatory Affairs with medical devices or digital health experience.
The predicted salary is between 50000 - 60000 £ per year.
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.
Your primary focus will be leading the execution of the regulatory strategy for the Si SU Health platform, including:
- New product registration (Class I 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
- 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.
Regulatory Affairs Specialist (Medical Devices & Digital Health) in Warrington employer: SiSU Health UK
At SiSU Health, we pride ourselves on being a purpose-driven employer that values collaboration and employee growth. As an Operations Coordinator, you'll be part of a supportive team dedicated to making health information accessible, with opportunities for professional development and the chance to contribute to meaningful projects. Enjoy the flexibility of a fully remote role while working in a dynamic environment that encourages innovation and continuous improvement.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist (Medical Devices & Digital Health) in Warrington
✨Dive into Industry Groups
Join compliance and risk management groups on platforms like LinkedIn and Facebook. These communities often share temp job postings and insights. You’d be surprised at how many temporary gigs float around through word of mouth!
✨Showcase Your Expertise
Consider creating content on compliance topics that get you noticed—think LinkedIn articles or even a blog. This not only shows off your knowledge but can grab the attention of companies like SiSU Health UK when they’re searching for someone to fill a temporary position.
✨Tap into Recruitment Agencies
Reach out to recruitment agencies that specialise in compliance and risk roles. They’re usually in touch with companies looking to fill temporary roles, which can save us a lot of time in our job search.
✨Go Local with Networking
Attend local compliance and risk seminars or workshops. Meeting professionals in our area can open up temp opportunities, and it’s a great way to make your face known in the industry—plus, you might even meet someone from SiSU Health UK!
We think you need these skills to ace Regulatory Affairs Specialist (Medical Devices & Digital Health) in Warrington
Some tips for your application 🫡
Show Your Compliance Know-How:When you’re applying for a compliance-risk role like Regulatory Affairs Specialist (Medical Devices & Digital Health), make sure to highlight your understanding of industry regulations and risk management principles. Mention any relevant coursework, certifications, or projects that showcase your expertise in these areas—it's what sets you apart!
Highlight Your Analytical Skills:In the compliance-risk field, strong analytical skills are essential. Talk about your experiences that required critical thinking and data analysis, whether in past roles, internships, or academic projects. Show us how you've identified risks and implemented solutions in the past.
Tailor Your CV for the Temporary Role:Since this is a temporary role, focus on your availability and flexibility in your CV. Highlight any previous short-term roles or projects that demonstrate your ability to adapt quickly and deliver results in a fast-paced environment. This helps employers see you as an easy fit in their team!
A Concise Cover Letter is Key:Keep your cover letter short and focused! Explain why you're interested in the compliance-risk area specifically for this temporary position at SiSU Health UK. Mention what you hope to learn and achieve, showing your enthusiasm and motivation to contribute positively during your time there.
How to prepare for a job interview at SiSU Health UK
✨Know Your Compliance Basics
Make sure you're clued up on the key compliance and risk regulations pertinent to the industry you're applying to. Understanding frameworks like GDPR or AML will not only impress but also show that you’re ready to hit the ground running in your temporary role at SiSU Health UK.
✨Prepare for Scenarios
Expect scenario-based questions that test your problem-solving skills. They might ask how you'd handle a specific compliance issue. Think through real situations you’ve encountered in past roles or study hypothetical cases to showcase your analytical skills and practical judgement during the interview.
✨Highlight Your Adaptability
Since this is a temporary position, emphasise your ability to adapt quickly to new environments and team dynamics. Share examples of how you’ve successfully adjusted to changes in past roles and how this flexibility can benefit SiSU Health UK in the short term.
✨Gather Your Technical Tools
Familiarise yourself with commonly used compliance tools or software, as they might come up in the interview. If you've used tools for risk assessments or compliance tracking, mention those and be ready to discuss how they can streamline processes at SiSU Health UK.
