TOGL(Holdings)Limited is a diagnostics company focused on diseases of the gastrointestinal tract. Our current research and validation programme targets accurate and efficient triage of patients with symptoms of colorectal cancer (CRC). We are looking for proactive, experienced, focused, and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company. As we progress towards commercialising a test for CRC, we are looking for a Regulatory Manager to lead the development process through relevant regulatory pathways.
We are seeking a detail-oriented and experienced Quality Assurance Specialist with strong knowledge of ISO 13485 and electronic Quality Management Systems (eQMS), particularly Greenlight Guru. The successful candidate will support and maintain the Quality Management System (QMS), ensure compliance with regulatory requirements, and deliver effective training to users across all aspects of quality assurance processes. Excellent Training competence is required.
Key Responsibilities
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Maintain and improve the Quality Management System in compliance with ISO 13485 and applicable regulatory requirements.
- Administer and support the Greenlight Guru eQMS platform, including document control, CAPA, training records, audits, and change management.
- Create, review, revise, and approve quality documentation such as SOPs, work instructions, forms, and policies.
- Conduct internal audits and support external audits by notified bodies, customers, and regulatory agencies.
- Manage CAPA investigations, non-conformances, deviations, and risk management activities.
- Ensure proper document control and record retention processes are maintained.
- Monitor quality metrics and prepare reports for management review.
- Train employees and system users on quality assurance procedures, ISO 13485 requirements, and Greenlight Guru eQMS functionality.
- Provide onboarding and refresher training to staff on QMS processes and compliance expectations.
- Support supplier quality activities, including evaluations and audits where required.
- Collaborate with cross-functional teams including Regulatory Affairs, Manufacturing, Engineering, and Operations.
- Assist in continuous improvement initiatives and quality system enhancements.
Supplier Quality Management
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Evaluate, qualify, approve, and monitor suppliers and contract manufacturers.
- Conduct supplier risk assessments and maintain Approved Supplier Lists (ASL).
- Lead supplier audits (remote and onsite) in accordance with ISO 13485 requirements.
- Monitor supplier KPIs including quality, delivery, responsiveness, and non-conformance trends.
Support supplier change notifications and assess impact on product quality and regulatory compliance.
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Requirements
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Bachelor’s degree in Life Sciences, Engineering, Quality Management, or related discipline.
- Proven experience working within an ISO 13485-certified environment.
- Hands-on experience using Greenlight Guru or similar eQMS platforms.
- Strong understanding of medical device quality management systems and regulatory compliance.
- Experience delivering training and supporting users in quality systems and procedures.
- Knowledge of CAPA, risk management, document control, and audit processes.
- Excellent communication, organizational, and problem-solving skills.
- Proficiency in Microsoft Office applications.
Preferred Qualifications
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Internal Auditor certification for ISO 13485.
- Experience in medical devices.
- Familiarity with ISO 13485, ISO 14971, ISO 15189 and EU MDR requirements.
Key Competencies
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Attention to detail
- Regulatory awareness
- Training and coaching ability
- Analytical thinking
- Strong documentation skills
- Team collaboration
- Continuous improvement mindset
Benefits
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25 days annual leave (plus bank holidays).
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Pension contribution.
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Competitive Salary.
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Employee wellbeing initiatives.
