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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 60000 - 80000 £ 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 employer: SciPro
Contact Detail:
SciPro Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Specialist
✨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 us that you understand their mission and how your skills can help them scale effectively. Tailor your examples to highlight your experience with compliance and quality management.
✨Tip Number 3
Don’t just wait for job postings! Keep an eye on our website and apply directly. Sometimes, the best opportunities come from being proactive and showing your enthusiasm for the role before it’s even advertised.
✨Tip Number 4
Follow up after interviews with a thank-you note. It’s a simple gesture that shows your appreciation and keeps you fresh in their minds. Mention something specific from the interview to remind them why you’re a great fit!
We think you need these skills to ace Quality Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV speaks directly to the Quality Specialist role. Highlight your experience with ISO standards and any work you've done in regulated environments. 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 compliance and how you can contribute to our fast-growing team. Let us know what excites you about working in the healthcare tech space.
Showcase Relevant Experience: When detailing your experience, focus on specific examples that demonstrate your ownership of Quality Management Systems and your involvement in audits. We love seeing concrete achievements that show how you’ve made an impact!
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people. Don’t miss out!
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 healthcare. Be ready to discuss how you can ensure compliance while allowing the product to scale effectively, demonstrating your strategic thinking.
✨Be Ready for Scenario Questions
Expect questions about how you'd handle audits, inspections, and CAPAs. Think through some scenarios beforehand so you can provide clear, structured responses that showcase your problem-solving skills.