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- Tasks: Own and evolve the Quality Management System while ensuring compliance across the business.
- Company: Fast-growing tech company in the healthcare space with a focus on innovation.
- Benefits: Hybrid working model, competitive salary, and opportunities for career growth.
- Other info: Clear pathway to grow into a Clinical Safety Officer role.
- Why this job: Make a real impact in healthcare by shaping compliance and quality processes.
- Qualifications: Experience in regulated environments and strong knowledge of ISO standards required.
The predicted salary is between 50000 - 65000 £ per year.
About the Company
We’re working with a fast-growing, venture-backed technology company operating within the healthcare space. Their product is already being used in live environments with large enterprise customers, delivering measurable improvements in efficiency and allowing end users to focus more on high-value tasks. Following recent funding, the company is now entering a key growth phase as they scale their product and expand adoption.
The Role
This is a high-impact position responsible for owning and shaping how compliance operates across the business. Sitting at the intersection of product, engineering, and operations, you will ensure regulatory requirements are met while enabling the company to move quickly and scale effectively.
You will take full ownership of the Quality Management System (QMS), oversee medical device compliance, and act as the internal lead for ISO standards. This role combines strategic oversight with hands-on execution and will be critical in building scalable, audit-ready processes. There is also a clear pathway to take on (or grow into) a Clinical Safety Officer (CSO) position, contributing to clinical risk management and safety governance as the product evolves.
Key Responsibilities
- Own and evolve the company’s Quality Management System (QMS)
- Ensure ongoing compliance as the product develops (features, integrations, deployments)
- Work closely with product and engineering teams to embed compliance into development processes
- Act as the internal lead for ISO standards (including ISO 13485 and ISO 27001)
- Maintain audit readiness across documentation, policies, and controls
- Lead preparation for audits, inspections, and certifications
- Track and manage corrective and preventative actions (CAPAs)
- Maintain relevant certifications and regulatory approvals
- Manage relationships with external compliance partners and ensure delivery of key obligations
- Support clinical safety processes, including risk assessments and governance frameworks
- Act as a cross-functional partner, translating regulatory requirements into practical business decisions
Requirements
- Experience working within a regulated environment, ideally software as a medical device (SaMD)
- Strong knowledge of ISO standards, particularly ISO 13485 and ISO 27001
- Experience owning or contributing to a QMS
- Experience supporting audits and maintaining certifications
- Comfortable working in a fast-paced, product-led organisation
Location: London-based, with a hybrid working model (3 days in-office)
Quality Specialist in London employer: SciPro
Contact Detail:
SciPro Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Specialist in London
✨Tip Number 1
Network like a pro! Reach out to people in the healthcare tech space, especially those who work at companies you're interested in. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s product and its impact on efficiency. Show them you’re not just another candidate; you’re genuinely excited about how their tech is changing the game in healthcare.
✨Tip Number 3
Don’t forget to showcase your hands-on experience with QMS and ISO standards during interviews. Bring examples of how you've tackled compliance challenges in the past – it’ll show you’re ready to hit the ground running!
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Quality Specialist in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Specialist role. Highlight your experience with ISO standards and any relevant compliance work you've done. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality management in healthcare tech. Share specific examples of how you've contributed to compliance in previous roles, and let us know why you want to join our team.
Showcase Your Problem-Solving Skills: In your application, don’t forget to mention times when you've tackled challenges in a regulated environment. We love candidates who can think on their feet and come up with practical solutions, so share those stories with us!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen to be part of our journey!
How to prepare for a job interview at SciPro
✨Know Your ISO Standards
Make sure you brush up on ISO 13485 and ISO 27001 before the interview. Being able to discuss these standards confidently will show that you understand the compliance landscape and can hit the ground running.
✨Showcase Your QMS Experience
Prepare specific examples of how you've owned or contributed to a Quality Management System in the past. Highlight any improvements you made and how they impacted compliance and efficiency.
✨Understand the Product and Its Impact
Research the company's product and its role in the healthcare space. Be ready to discuss how you can ensure compliance while allowing the product to scale effectively, demonstrating your strategic thinking.
✨Prepare for Scenario Questions
Expect questions about how you'd handle audits, inspections, and CAPAs. Think through potential scenarios and how you would approach them, showing your problem-solving skills and readiness for hands-on execution.