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 a 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.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist (Medical Devices & Digital Health) in Glasgow
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like SiSU Health UK.
We think you need these skills to ace Regulatory Affairs Specialist (Medical Devices & Digital Health) in Glasgow
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at SiSU Health UK.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at SiSU Health UK. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at SiSU Health UK
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with SiSU Health UK.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help SiSU Health UK achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
