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 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 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 provided.