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For Companies At a Glance
- Tasks: Own and shape compliance processes while ensuring regulatory requirements are met.
- 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 ensuring product compliance and safety.
- Qualifications: Experience in regulated environments and strong knowledge of ISO standards.
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
- 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 City of London employer: SciPro
Contact Detail:
SciPro Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Specialist in City of 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 products and values. Show them you’re not just another candidate; you’re genuinely excited about their mission and how you can contribute to their growth.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your interest. It keeps you fresh in their minds and shows your enthusiasm.
✨Tip Number 4
Apply through our website! We’ve got a streamlined process that makes it easy for you to showcase your skills. Plus, it helps us keep track of your application and gives you a better chance to shine.
We think you need these skills to ace Quality Specialist in City of 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 the healthcare tech space. Let us know how you can contribute to our mission and what excites you about this role.
Showcase Relevant Experience: When filling out your application, be specific about your experience in regulated environments and your familiarity with QMS. We love seeing concrete examples of how you've ensured compliance and supported audits in the past.
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about our company culture and values.
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 regulatory landscape and can contribute effectively to the Quality Management System.
✨Showcase Your Compliance Experience
Prepare specific examples from your past roles where you've ensured compliance in a regulated environment. Highlight any experience with audits or maintaining certifications, as this will demonstrate your hands-on knowledge and ability to manage compliance effectively.
✨Understand the Product and Its Impact
Research the company's product and how it operates within the healthcare space. Be ready to discuss how you can help embed compliance into the development processes, ensuring that the product scales while meeting regulatory requirements.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about how you would handle situations involving corrective and preventative actions (CAPAs) or preparing for audits, and be prepared to articulate your thought process clearly.