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

SOPHiA GENETICS; Rolle; Presencial; CHF 22 000 - 31 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Monthly meal benefit

Paid internship according to degree

Resumo da oferta

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

Qualificações

• 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.

Conhecimentos

Detail-oriented

Organized

Technical writing

Microsoft Office

English communication

Team player

Formação académica

Life Sciences or related field

Molecular Biology

Genomics

Biomedical Engineering

Engineering

Ferramentas

eQMS

Descrição da oferta de emprego

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.

You might be studying Life Sciences, Molecular Biology, Genomics, Biomedical Engineering, Engineering, Quality Management or a related field.

You’ll probably enjoy this internship if:

• You’re detail-oriented and organized. You enjoy structured work and understand the importance of accuracy.
• You have strong technical writing skills. You’re comfortable reviewing, organizing and maintaining technical documentation.
• You’re comfortable with Microsoft Office. Experience with electronic Quality Management Systems (eQMS) is a plus.
• You’re interested in medical device regulations. Knowledge of ISO 13485, IEC 62304, IVDR or software lifecycle concepts is an advantage.
• You’re proactive and curious. You enjoy learning, taking initiative and asking questions.
• You’re a team player. You communicate clearly, collaborate well and have a good command of English.

Previous experience in a regulated environment is a plus, but your motivation, attention to detail and willingness to learn are just as important.

Alongside the experience you’ll gain through your projects, you will:

• Be treated as part of the team and take part in company life and events alongside our regular employees.
• Build your network by connecting with colleagues across different teams, functions and backgrounds in an international environment.
• Learn from experienced colleagues and create connections that can support your professional development beyond the internship.
• Join company events and activities, giving you plenty of opportunities to meet people beyond your immediate team.
• Receive a monthly meal benefit to support your lunches during the working week.
• Receive a paid internship - all internships at SOPHiA GENETICS are compensated according to degree level and local practices.

Duration: 6 months

All SOPHiA GENETICS internships and apprenticeships are paid according to each country's best practices and degree level.