Software Engineer

Our client is an innovative biotech company using AI/ML to power software medical devices that enable personalised cancer vaccines and fight infectious diseases. Their mission is to combine bioinformatics, immunology, and automation to accelerate life-saving treatments.

The role

We’re looking for a Software Engineer with a strong automation mindset to join the Quality Assurance and Regulatory Affairs team. This is a key role for automating documentation and traceability workflows, supporting software lifecycle activities, and ensuring regulatory compliance for AI/ML-enabled medical software.

What you’ll do

• Automate regulatory and quality documentation workflows (e.g., risk reports, traceability matrices) using tools like GitHub, Jira, and Confluence.

• Support verification/validation protocols and regulatory submissions (FDA, EMA, etc.).

• Build and maintain CI/CD pipelines with GitHub Actions to streamline code quality checks and testing.

• Collaborate with cross-functional teams (data science, bioinformatics, QA/RA) to ensure traceability and compliance across the product lifecycle.

• Contribute to AI/ML model validation and risk assessments (e.g., FMEA).

• Improve and maintain structured documentation in Markdown, reStructuredText, or similar.

Requirements

• Degree in Software Engineering or Computer Science.

• 2+ years in software development, QA, or regulatory affairs—preferably in SaMD.

• Strong Python skills and experience with automation, CI/CD, Git, and containerization.

• Experience automating documentation or working in regulated environments.

• Excellent communication skills and attention to detail.

Nice to have

• Knowledge of regulatory standards (IEC 62304, ISO 13485, FDA 21 CFR Part 820).

• Familiarity with AI/ML workflows, bioinformatics, or personalized medicine.

• Cloud experience (e.g., GCP).

Why apply?

• Work on meaningful tech that directly impacts patient lives.

• Diverse, interdisciplinary team and collaborative culture.

• Personal learning and tech budgets.

• Flexible hours, hybrid work model, excellent benefits, and competitive salary.

• Time off during the holidays and a strong focus on work-life balance.

Your consultant

As a Senior Recruitment Consultant at Aspire Life Sciences, Julien Funes' expertise lies at the nexus of technology and life sciences. He recruits top Machine Learning and data talent for Biotech and life sciences startups across Europe and North America. He is committed to advancing the industry by sourcing and securing top-tier talent for roles in these critical sectors. His approach enables him to effectively match candidates with opportunities where technological innovation meets life science excellence.