Senior QARA Engineer - Software

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 RoleWe 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 (VandV) 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 and 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, VandV 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 assurance

Comprehensive mental health support and resources

Unlimited holiday allowance (+ bank holidays)

Hybrid working (minimum 3 days in-office)

Quarterly work-from-anywhere policy

Weekly lunches

Breakfast and snacks ..... full job details .....