PeriVision is a digital health company addressing the large unmet need for more efficient and effective visual field testing. By combining AI algorithms, virtual reality, and cloud computing, the team develops software-based medical solutions with a disease-centric approach, initially focusing on glaucoma.
The role
As a QA & Regulatory Specialist, you will work cross-functionally to ensure the quality, safety, and regulatory compliance of software as a medical device (SaMD). You will support quality management system activities, software verification and validation, risk management, and regulatory documentation across multiple frameworks.
Key requirements
Background in quality assurance, regulatory affairs, biomedical engineering, software engineering, or related field
Experience or strong interest in medical device software and digital health
Fluency in English (written and verbal)
Familiarity with standards such as ISO 13485, IEC 62304, ISO 14971 is a plus