Regulatory & Quality Intern, IVD Devices (6‑Month, Paid)

SOPHiA GENETICS; Rolle; Presencial; CHF 22.000 - 31.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Monthly meal benefit

Paid internship according to degree

Descripción de la vacante

SOPHiA GENETICS, Rolle, Switzerland, offers a six-month internship in Quality Management and Regulatory Affairs. You will work with experienced colleagues on real projects to support regulatory compliance for our in vitro diagnostic devices.

This paid internship develops hands-on skills in ISO 13485, IEC 62304 and GDP, including change control, non-conformity management and CAPAs. You’ll help consolidate regulatory documentation, keep controlled documents up to date and collaborate with R&D, QA

Formación

• Pursuing a degree in Life Sciences, Molecular Biology, Genomics, Biomedical Engineering, Engineering, Quality Management or a related field.
• Detail-oriented and organized with strong written communication.
• Experience with Microsoft Office; familiarity with eQMS is a plus.
• Interest in medical device regulations (ISO 13485, IEC 62304, IVDR) is advantageous.
• Excellent teamwork and English communication.

Responsabilidades

• Support regulatory compliance by updating the Design & Development File for SOPHiA DDM Dx Mode in line with ISO 13485 and IEC 62304.
• Contribute to technical documentation and ensure accuracy and consistency.
• Assist with change control, non-conformity management and CAPAs.
• Maintain documentation in the document management system following GDP.
• Collaborate with R&D, Quality Assurance and Regulatory Affairs to understand lifecycle quality and compliance.

Conocimientos

Detail-oriented

Organized

Technical writing

Microsoft Office

English communication

Team player

Educación

Life Sciences or related field

Molecular Biology

Genomics

Biomedical Engineering

Engineering

Herramientas

eQMS

Descripción del empleo

SOPHiA GENETICS, Rolle, Switzerland, offers a six-month internship in Quality Management and Regulatory Affairs. You will work with experienced colleagues on real projects to support regulatory compliance for our in vitro diagnostic devices.

This paid internship develops hands-on skills in ISO 13485, IEC 62304 and GDP, including change control, non-conformity management and CAPAs. You’ll help consolidate regulatory documentation, keep controlled documents up to date and collaborate with R&D, QA