Regulatory Affairs Intern - In Vitro Diagnostic (IVD) medical device — SOPHiA GENETICS

Full description

At SOPHiA GENETICS , we are building the future of AI-assisted, data-driven medicine. Our technology helps healthcare professionals make sense of complex data, with the ambition of improving outcomes for patients with cancer and rare diseases. Behind every medical technology are rigorous quality processes and regulatory requirements that help ensure its reliability and safety. And you could be part of that journey. Join us for a six-month internship and gain hands-on experience in Quality Management and Regulatory Affairs, supporting the compliance of our in vitro diagnostic (IVD) medical devices.

What you'll work on

You'll work alongside experienced colleagues on real projects, helping ensure our products meet regulatory and quality standards.

• Support regulatory compliance. Review and update the Design & Development File for SOPHiA DDM™ Dx Mode in line with ISO 13485 and IEC 62304.
• Work on technical documentation. Help consolidate regulatory documentation for our IVD products, ensuring accuracy, completeness and consistency.
• Get involved in quality processes. Support change control, non-conformity management and Corrective and Preventive Actions (CAPAs).
• Keep documentation organized. Update controlled documents in our document management system, following Good Documentation Practices (GDP).
• Collaborate across teams. Work with colleagues from R&D, Quality Assurance and Regulatory Affairs to understand how quality and compliance are maintained throughout the product lifecycle.