Breast AI QA & Regulatory Lead

ScreenPoint Medical; Nijmegen; On-site; EUR 70,000 - 90,000; Full time

Job summary

ScreenPoint Medical is seeking a Product QA/RA Officer to bridge innovative engineering and global compliance. You will own Technical Files and DHF, ensure MDR/FDA readiness, and guide cross-functional teams in risk management and software verification.

The role emphasizes AI-enabled regulatory research and vigilant post-market surveillance. You will collaborate with Engineering, Product Management, and Clinical teams to ensure compliant-by-design Breast AI innovations reach clinicians safely

Qualifications

• At least 3 years of QA/RA experience in SaMD (medical device software).
• Ability to translate regulatory language into technical requirements for developers.
• Excellent command of English for cross-functional communication.

Responsibilities

• Act as QA/RA stakeholder across design projects; ensure regulatory requirements integrated from inception to launch.
• Own and maintain Technical Files and DHF; ensure EU MDR, FDA and other global requirements compliance.
• Lead post-market surveillance activities; investigate, perform root-cause analysis and ensure timely resolutions.
• Monitor regulatory standards (AI, cybersecurity) and assess impact on product portfolio; flag regulatory filings or notifications when needed.
• Provide guidance on risk management, usability engineering, and software verification/validation strategies to Engineering and Clinical teams.
• Support global submissions by producing high-quality regulatory documentation for EU MDR, US 510(k), etc.
• Promote intelligent use of AI tools to improve regulatory research and QA/RA processes, ensuring compliance.

Skills

QA/RA expertise

Regulatory translation

English communication

Education

Technical degree in Software Engineering

Biomedical Engineering

Tools

Claude

ChatGPT

Job description

ScreenPoint Medical is seeking a Product QA/RA Officer to bridge innovative engineering and global compliance. You will own Technical Files and DHF, ensure MDR/FDA readiness, and guide cross-functional teams in risk management and software verification.

The role emphasizes AI-enabled regulatory research and vigilant post-market surveillance. You will collaborate with Engineering, Product Management, and Clinical teams to ensure compliant-by-design Breast AI innovations reach clinicians safely