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.
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
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. 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
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
~ Proven working knowledge of quality system regulations (FDA 21 CFR Part 820)
~ Experience with document control systems and eQMS tools
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