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- Tasks: Join our team to manage quality systems and ensure compliance with regulatory standards.
- 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 shaping the future of healthcare technology while making a real impact.
- Qualifications: A Bachelor's degree and 3+ years in quality or regulatory roles in the medical device industry are essential.
- Other info: Flexibility is key; you'll collaborate closely with engineers and support various startup activities.
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 fields, especially those who work in medical devices. Attend industry events or join online forums to connect with others and gain insights that could be beneficial during your application process.
✨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 by discussing how you've successfully managed multiple priorities in a fast-paced environment. This is particularly important for a startup like Nami Surgical, where roles can evolve quickly.
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 your experience aligns with these standards and how you can contribute to maintaining compliance in the role.
✨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.
✨Adaptability is Key
Since Nami Surgical is a startup, showcase your flexibility and ability to manage multiple priorities. Discuss instances where you've adapted to changing needs or taken on diverse responsibilities in previous roles.
