IVD Regulatory Affairs & Quality Intern

SOPHiA GENETICS; Vaud; Hybrid; CHF 17,000 - 26,000; Full time

Benefits offered by this job

Monthly meal benefit

Paid internship

Job summary

SOPHiA GENETICS in Vaud, Switzerland invites you to a six-month internship in Quality Management and Regulatory Affairs, supporting compliance of in vitro diagnostic (IVD) medical devices. You’ll work on real projects alongside experienced colleagues to ensure regulatory and quality standards are met.

You’ll collaborate with R&D, QA and Regulatory Affairs to update documentation, contribute to GDP-compliant processes, and help manage CAPAs, change controls and documentation updates throughout

Qualifications

• Pursuing Life Sciences or related field with interest in regulatory and quality systems.
• Strong writing and documentation skills are essential.
• Familiarity with ISO 13485, IEC 62304 or software lifecycle concepts is a plus.

Responsibilities

• Support regulatory compliance by updating Design & Development File in line with ISO 13485 and IEC 62304.
• Contribute to technical documentation consolidation for IVD products.
• Assist with change control, non-conformity management and CAPAs.
• Maintain controlled documents following Good Documentation Practices (GDP).
• Collaborate with R&D, QA and Regulatory Affairs to understand lifecycle quality.

Skills

Detail oriented

Technical writing

MS Office

Team player

Education

Pursuing Life Sciences / Genomics / Biomedical Engineering

Tools

eQMS

Job description

SOPHiA GENETICS in Vaud, Switzerland invites you to a six-month internship in Quality Management and Regulatory Affairs, supporting compliance of in vitro diagnostic (IVD) medical devices. You’ll work on real projects alongside experienced colleagues to ensure regulatory and quality standards are met.

You’ll collaborate with R&D, QA and Regulatory Affairs to update documentation, contribute to GDP-compliant processes, and help manage CAPAs, change controls and documentation updates throughout