Product QA/RA Officer
Core
Bridge between engineering and global compliance, ensuring medical device software (SaMD) is built compliant by design and reaches clinicians safely.
Role type
Product Quality Assurance / Regulatory Affairs Officer for Medical Device Software
Builds
Breast AI software products for radiologists to detect cancer earlier
Domain
Healthcare / Medical Imaging / AI / Regulatory Compliance
Deliverable
production ML models | infrastructure
Required skills
Medical device software QA/RA, EU MDR, FDA 21 CFR 820, IEC 62304, ISO 14971, IEC 62366, Technical File compilation, Post-market surveillance, Root cause analysis, Risk management, Usability engineering, Software verification/validation
Preferred skills
AI/Machine Learning validation, Cybersecurity frameworks, Cloud-based SaaS in regulated environments, Breast radiology workflows, DICOM
Technologies
DICOM, Cloud-based SaaS
Responsibilities
Integrate regulatory requirements into product roadmap from inception to launch; Compile, maintain, and review Technical Files and Design History Files; Support product complaints, nonconforming products, and lead investigations; Monitor evolving standards (AI, Cybersecurity) for regulatory impact; Advise Engineering and Clinical teams on risk management and validation strategies; Provide technical documentation for global market access submissions
Seniority
Mid-level, hands-on IC
