Regulatory & Quality Lead – AI IVD Diagnostics

We are a growing startup developing AI products for medical diagnosis, and we need someone to help us navigate regulatory changes to ensure compliance. This role involves certifying AI models for microscopy images in hematology and infectious diseases.

Requirements

• Experience in SaMD regulatory frameworks and compliance activities.
• Experience with EU medical device regulations, including IVDR and/or MDR.
• Understanding of emerging AI regulations in healthcare, including the EU AI Act.
• University degree in Engineering, Medicine, Pharmacy, Law, or another relevant scientific discipline.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance