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- Tasks: Join our team to manage quality systems and regulatory compliance in a dynamic startup environment.
- Company: Nami Surgical is an innovative medical device company based in Glasgow, focused on quality and regulatory excellence.
- Benefits: Enjoy a permanent position with opportunities for growth and collaboration in a flexible work culture.
- Why this job: Be part of a passionate team shaping the future of medical technology while ensuring top-notch quality standards.
- Qualifications: Bachelor's degree in life sciences or engineering; 3+ years in quality/regulatory roles in medical devices required.
- Other info: This role offers a chance to influence product design and development directly.
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
- Required: 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 (, , United Kingdom) employer: Kleboe Jardine Ltd
Contact Detail:
Kleboe Jardine Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Specialist (, , United Kingdom)
✨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 fields, especially those working in medical devices. Attend industry events or join online forums to connect with others who can provide insights and potentially refer you to opportunities.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to quality management systems in previous roles. Highlight your experience with document control and internal audits, as these are key responsibilities for the position.
✨Tip Number 4
Show your flexibility and adaptability by being ready to discuss how you've successfully managed multiple priorities in a fast-paced environment. This is crucial for a startup like Nami Surgical, where roles can evolve quickly.
We think you need these skills to ace Quality Specialist (, , United Kingdom)
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Quality Specialist position. Familiarise yourself with ISO 13485 and other relevant regulatory standards to demonstrate your knowledge in your application.
Tailor Your CV: Customise your CV to highlight your experience in quality and regulatory roles, particularly within the medical device industry. Emphasise your familiarity with quality management systems and document control processes, as these are crucial for the role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and regulatory compliance. Mention specific experiences that align with the job description, such as managing internal audits or developing QMS documentation, to make your application stand out.
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 essential 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 your experience aligns with these standards and how you can contribute to maintaining compliance within the company.
✨Showcase Your Experience
Highlight your previous roles in quality and regulatory positions, especially within the medical device industry. Use specific examples to demonstrate your understanding of quality management systems and document control processes.
✨Collaborative Mindset
Emphasise your ability to work closely with cross-functional teams, particularly R&D and operations. Share examples of how you've successfully collaborated on projects to meet quality and regulatory requirements.
✨Stay Updated on Regulations
Demonstrate your proactive approach to monitoring changes in global regulatory standards. Discuss how you keep yourself informed and how you would communicate these updates to your team effectively.
