Who we are

2.2 billion people suffer from vision impairments of which 50% could be prevented or cured according to the World Health Organization. At PeriVision, we combine AI algorithms, virtual reality and cloud computing to build the next generation systems to test visual function. To optimize our tools for clinical value, we take a disease-centric approach. The first condition we are targeting is glaucoma. We address the large unmet need for more efficient and effective visual field testing in glaucoma patients.

How your role fits in

As a QA & Regulatory Specialist, you will work cross-functionally with the entire team, playing a key role in ensuring the quality, safety, and regulatory compliance of our software-based medical solution. You will support the software engineering team in planning, implementing, and maintaining quality and testing processes in line with applicable medical device regulations.

You will also closely support the Head of Quality & Regulatory Affairs with regulatory change management and documentation across multiple regulatory frameworks.

Your responsibilities

Quality Assurance

• Support the planning, implementation, and maintenance of the Quality Management System (QMS)
• Collaborate with software engineers to define and maintain quality, verification, and validation activities
• Ensure software development and testing processes comply with applicable medical device standards and regulations
• Assist in risk management activities, including documentation and traceability
• Support internal audits and continuous improvement initiatives

Regulatory Affairs

• Assist in maintaining regulatory documentation for software as a medical device (SaMD)
• Support regulatory change management activities across different jurisdictions
• Help ensure ongoing compliance with relevant standards and regulations (e.g., ISO 13485, IEC 62304, MDR, FDA as applicable)
• Contribute to regulatory submissions and technical documentation under guidance of the Head of Quality & Regulatory

Your qualifications & Profile

• Background in quality assurance, regulatory affairs, biomedical engineering, software engineering, or a related field
• Written and verbal fluency in English
• Experience or strong interest in medical device software and digital health
• Structured, detail-oriented, and comfortable working in a regulated environment
• Strong communication skills and ability to collaborate across disciplines
• Proactive mindset with a willingness to grow in a fast-paced startup environment
• would be a plus: Familiarity with medical device quality and regulatory standards (e.g., ISO 13485, IEC 62304, ISO 14971)
• would be a plus : Location in greater Lausanne area

Your mindset

• Team player: compassion and attention for people's concerns and obstacles in their daily routines is second nature for you; you collaborate and communicate effectively (verbal & written).
• Excellent soft skills.
• Proactive: you take on ownership and drive projects forward.
• Efficient and goal oriented: you can manage projects and get to results.
• Curious and eager to learn and adapt to the fast evolution of technologies.

What we offer

• Compensation: benefit from a competitive compensation package.
• A meaningful role contributing to improved eye care and patient outcomes
• Flexible working arrangement (40–50%, Possibility of hybrid work.)
• Opportunity to work at the intersection of AI, VR, and healthcare
• Close collaboration with a motivated, young, dynamic and multidisciplinary team.
• Responsibility: co-develop and shape a young company from the beginning.

If this sounds exciting, please reach out to klaus.hammer@perivision.com