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SOPHiA GENETICS is a healthcare technology democratizing data-driven medicine.
The Role
Six-month Regulatory Affairs internship supporting quality and regulatory compliance for in vitro diagnostic medical devices. Responsibilities include maintaining design and development files, consolidating technical documentation, supporting change control, non-conformity management and CAPAs, updating controlled documents in an eQMS, and collaborating with R&D, Quality Assurance and Regulatory Affairs teams.
Summary Generated by Built In
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.
Requirements
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:
Previous experience in a regulated environment is a plus, but your motivation, attention to detail and willingness to learn are just as important.
Benefits
Alongside the experience you'll gain through your projects, you will:
Duration: 6 months
All SOPHiA GENETICS internships and apprenticeships are paid according to each country's best practices and degree level.
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.
Requirements
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.
Benefits
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.
Skills Required
- Currently studying Life Sciences, Molecular Biology, Genomics, Biomedical Engineering, Engineering, Quality Management, or a related field
- Strong technical writing skills and ability to review and maintain technical documentation
- Proficiency with Microsoft Office
- Strong English communication skills
- Detail-oriented, organized, proactive, curious, and collaborative working style
- Experience with electronic Quality Management Systems (eQMS)
- Knowledge of ISO 13485, IEC 62304, IVDR, or software lifecycle concepts
- Previous experience in a regulated environment
What the Team is Saying
Dan
Senior Director, Revenue Accounting
Angela
Senior Sales Executive
SOPHiA GENETICS Compensation & Benefits Highlights
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Healthcare Strength — Healthcare coverage includes medical, dental, and vision with roughly 90% employer-paid premiums, plus telehealth and company‑paid short- and long‑term disability and life insurance. This scope positions health benefits as a standout element of the U.S. offering.
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Leave & Time Off Breadth — Time off includes about 20 days of PTO that increases to 25 with tenure, 5 sick days, and roughly 14 paid public holidays. The structure provides a sizable bank of paid time away.
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Retirement Support — Retirement provisions feature a 401(k) with a 4% company match. This adds tangible long‑term value alongside salary.
SOPHiA GENETICS Insights
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The Company
What We Do
SOPHiA GENETICS (Nasdaq: SOPH) is a healthcare technology company dedicated to establishing the practice of data-driven medicine as the standard of care and for life sciences research. It is the creator of the SOPHiA DDM™ Platform, a cloud-based SaaS platform capable of analyzing data and generating insights from complex multimodal data sets and different diagnostic modalities. The SOPHiA DDM™ Platform and related solutions, products and services are currently used by more than 780 hospital, laboratory, and biopharma institutions globally.
Why Work With Us
This is not just a tech company, it’s not only about algorithms and data, it’s more than that. It’s bold, visionary, and altruistic. Democratizing health outcomes is bigger than a spreadsheet, a sale, or a line of code. It’s all of those things coming together with driven, curious people to deliver this audacious vision.
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SOPHiA GENETICS Teams
SOPHiA GENETICS Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
3 days a week
