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At CoMind, we are developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring. In joining us, you will be helping to create cutting-edge technologies that will improve how we diagnose and treat brain disorders, ultimately improving and saving the lives of patients across the world.
The Role
We are seeking a QA/RA Engineer with a strong focus on software quality assurance and regulatory compliance for medical devices. You will play a crucial role in ensuring the software in our medical technology meets the highest quality and regulatory standards.
Responsibilities:
Develop, implement, and maintain software quality assurance (QA) processes in compliance with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR.
Lead software validation and verification (V&V) activities, including test planning, execution, and documentation.
Collaborate with software engineers to ensure software development lifecycle (SDLC) compliance, including risk management (ISO 14971) and cybersecurity considerations.
Support regulatory submissions (e.g., FDA 510(k), CE marking) by preparing software-related documentation such as Software Development Plans, Software Design History Files (DHF), and Software Bill of Materials (SBOM).
Ensure that non-conformances, CAPAs, and audits related to software are effectively addressed and documented.
Skills & Experience:
Demonstrable experience in QA/RA for software in medical devices or a related field
Strong knowledge of ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations for software
Experience with software validation, V&V testing, and risk management (ISO 14971)
Familiarity with software configuration management, cybersecurity standards, and AI/ML regulatory considerations is a plus
Hands-on experience with document control systems (e.g., eQMS), CAPA management, and audit processes
Strong analytical and problem-solving skills with a detail-oriented mindset
Excellent communication skills, with the ability to translate regulatory requirements into practical engineering processes.
Benefits:
Company equity plan
Company pension scheme
Private medical, dental and vision insurance
Group life insurance
Comprehensive mental health support and resources
Unlimited holiday allowance (+ bank holidays)
Weekly lunches
Breakfast and snacks provided.
CoMind London, England Office
3-7 Herbal Hill, London, United Kingdom
