IVD Regulatory & Quality Intern (6‑Month)

SOPHiA GENETICS; Schweiz; A distancia; CHF 20.000 - 26.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Monthly meal benefit

Paid internship

International environment

Descripción de la vacante

SOPHiA GENETICS offers a six-month internship in Quality Management and Regulatory Affairs to support the compliance of our in vitro diagnostic (IVD) medical devices. You’ll work alongside experienced colleagues on real projects, ensuring regulatory and quality standards are met across the lifecycle.

You’ll gain hands-on experience reviewing regulatory documentation, supporting change control and GDP, and collaborating with R&D, QA, and Regulatory Affairs in an international environment.

Formación

• Detail-oriented and organized approach to work.
• Strong technical writing skills for reviewing and maintaining documentation.
• Comfortable with Microsoft Office; eQMS experience is a plus.

Responsabilidades

• Review and update the Design & Development File for SOPHiA DDM Dx Mode per ISO 13485 and IEC 62304.
• Consolidate regulatory documentation for our IVD products, ensuring accuracy and completeness.
• Support change control, non-conformity management and CAPAs.
• Update controlled documents in our document management system following GDP.
• Collaborate with R&D, Quality Assurance and Regulatory Affairs across the product lifecycle.

Conocimientos

Detail-oriented

Organized

Technical writing

Team player

English communication

Educación

Life Sciences or related field

Herramientas

Microsoft Office

eQMS software

Descripción del empleo

SOPHiA GENETICS offers a six-month internship in Quality Management and Regulatory Affairs to support the compliance of our in vitro diagnostic (IVD) medical devices. You’ll work alongside experienced colleagues on real projects, ensuring regulatory and quality standards are met across the lifecycle.

You’ll gain hands-on experience reviewing regulatory documentation, supporting change control and GDP, and collaborating with R&D, QA, and Regulatory Affairs in an international environment.