Product QA/RA Officer

We are seeking a Product QA/RA Officer to join our team at ScreenPoint Medical, a leading company developing breast image analysis and machine learning applications. The successful candidate will be responsible for ensuring regulatory compliance and product quality, working closely with Engineering, Product Management, and Clinical teams. As a strategic guardian of product quality and regulatory alignment, you will design and develop solutions that meet global regulatory requirements, providing hands-on support and guidance to teams, and managing post-market feedback and technical documentation for global market access.

Requirements

• At least 3 years of experience in QA/RA specifically focused on Medical Device Software (SaMD)
• Technical degree (e.g., Software Engineering, Technical Medicine, Biomedical Engineering) or equivalent technical experience
• Deep knowledge of medical device standards such as IEC 62304, ISO 14971, and IEC 62366
• Familiarity with FDA regulations (21 CFR 820) and EU MDR
• Ability to translate complex regulatory language into actionable technical requirements for developers
• Excellent command of English

Benefits

• Competitive salary
• Opportunities for career growth and professional development
• Chance to work on innovative projects that improve health worldwide