Quality Specialist

JR United Kingdom; Ipswich; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading company in the medical device industry seeks a Quality/Regulatory Specialist to help establish and maintain a quality management system compliant with ISO 13485. This permanent position involves working closely with engineering and operations on compliance, documentation, and regulatory strategy.

Qualifications

• 3+ years in quality/regulatory roles in medical devices.
• In-depth knowledge of ISO 13485.
• Proven knowledge of FDA 21 CFR Part 820.

Responsibilities

• Develop and maintain ISO 13485-compliant QMS.
• Compile and maintain regulatory documentation.
• Manage document control processes.

Skills

Organizational Skills

Attention to Detail

Regulatory Knowledge

Document Control

Education

Bachelor's degree in life science or engineering

Tools

Document Control Systems

eQMS Tools

Job description

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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

Qualifications

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 [emailprotected] for a confidential discussion about the opportunity