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- Tasks: Join our team as a Quality Specialist, ensuring compliance and supporting quality management systems.
- Company: Nami Surgical is an innovative startup based in Glasgow, focused on medical device development.
- Benefits: Enjoy a permanent position with opportunities for growth and collaboration in a dynamic environment.
- Why this job: Be part of a passionate team, making a real impact in healthcare through quality and regulatory excellence.
- Qualifications: A Bachelor's degree and 3+ years in quality/regulatory roles in the medical device industry are essential.
- Other info: Flexibility is key; contribute to various startup activities while collaborating with engineers.
The predicted salary is between 36000 - 60000 £ per year.
Our client Nami Surgical have an exciting new opportunity for a Quality/ Regulatory Specialist to join the team on a permanent basis. Nami Surgical are based in Glasgow and this is a permanent position.
The Quality & Regulatory Associate/Specialist will be instrumental in establishing and maintaining our quality management system (QMS) in alignment with ISO 13485 and other regulatory standards. You will support day-to-day quality and regulatory functions—including document control, internal audits, and QMS development—while also flexibly contributing to a range of startup activities. A key part of your role will be collaborating closely with our dynamic team of engineers to help guide the design and development of both hardware and software in line with applicable quality and regulatory standards.
Key Responsibilities- Quality Management & Compliance
- Assist in the development, implementation, and maintenance of the ISO 13485-compliant QMS
- Manage and control quality documentation, including SOPs, work instructions, and forms
- Manage cross-functional change control process
- Support internal audits and CAPA processes
- Participate in risk management activities and design history file (DHF) development
- Regulatory Affairs
- Compile and maintain regulatory documentation (e.g. regulatory strategy documents, technical files)
- Monitor and interpret changes in global regulatory standards (e.g. FDA, EU MDR, ISO 13485, MDSAP) and proactively communicate relevant updates to development team and internal stakeholders
- Evaluate regulatory pathways and support strategic decision-making around market entry and expansion, identifying opportunities and risks across target regions
- Translate regulatory requirements into clear, actionable guidance for engineering, design, and operations teams
- Document Control
- Manage the document control process: versioning, approvals, distribution, and archival
- Train team members on document control procedures and QMS compliance
- Maintain electronic and/or paper-based quality records and logs
- Review technical documentation to ensure compliance with applicable standards
- Cross-Functional Support
- Work closely with R&D and operations teams to align on quality and regulatory requirements
- Support general business operations as needed—flexibility is key in our startup environment
- Contribute to team meetings, strategic planning, and process improvement initiatives
- Bachelor's degree in a life science, engineering, or related field
- 3+ years of experience in quality and/or regulatory roles within the medical device industry is essential
- In-depth knowledge of ISO 13485 is required
- Proven working knowledge of quality system regulations (FDA 21 CFR Part 820)
- Strong organizational skills with meticulous attention to detail
- Experience with document control systems and eQMS tools
- Ability to manage multiple priorities and adapt to evolving needs
Apply above or reach out to me at ak@kleboejardine.com for a confidential discussion about the opportunity.
Quality Specialist employer: Kleboe Jardine Ltd
Contact Detail:
Kleboe Jardine Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Specialist
✨Tip Number 1
Familiarise yourself with ISO 13485 and other relevant regulatory standards. Understanding these frameworks will not only help you in interviews but also demonstrate your commitment to quality management in the medical device industry.
✨Tip Number 2
Network with professionals in the quality and regulatory field, especially those who work in medical devices. Attend industry events or join online forums to connect with others and gain insights that could give you an edge in your application.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to quality management systems in previous roles. Highlighting your hands-on experience with document control and internal audits can set you apart from other candidates.
✨Tip Number 4
Show your flexibility and adaptability during the interview process. Since this role involves supporting various startup activities, emphasising your ability to manage multiple priorities and adapt to changing needs will resonate well with the hiring team.
We think you need these skills to ace Quality Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality and regulatory roles, particularly within the medical device industry. Emphasise your knowledge of ISO 13485 and any specific achievements that demonstrate your skills.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the key responsibilities mentioned in the job description. Explain how your background aligns with their needs, particularly in managing quality documentation and supporting internal audits.
Showcase Relevant Experience: In your application, provide examples of past projects or roles where you successfully implemented quality management systems or navigated regulatory requirements. This will help illustrate your capability to contribute effectively to Nami Surgical.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a Quality Specialist role.
How to prepare for a job interview at Kleboe Jardine Ltd
✨Know Your Standards
Familiarise yourself with ISO 13485 and other relevant regulatory standards. Be prepared to discuss how you have applied these standards in your previous roles, as this will demonstrate your expertise and understanding of the quality management system.
✨Showcase Your Experience
Highlight your experience in quality and regulatory roles within the medical device industry. Prepare specific examples of how you've managed document control, conducted internal audits, or contributed to CAPA processes to illustrate your hands-on experience.
✨Collaborative Mindset
Emphasise your ability to work closely with cross-functional teams, especially engineers. Share examples of how you've successfully collaborated on projects, ensuring that quality and regulatory requirements were met while supporting design and development.
✨Stay Updated on Regulations
Demonstrate your proactive approach by discussing how you keep up with changes in global regulatory standards. Mention any tools or strategies you use to monitor these changes and how you communicate updates to your team, showcasing your commitment to compliance.
