Regulatory Expert, Digital Pathology

Description

We are seeking an experienced Regulatory Affairs Expert in digital pathology to provide strategic and tactical regulatory leadership for digital pathology products, including software, image analysis algorithms, and integrated diagnostic systems.

This role serves as a key regulatory partner to R&D, Clinical, Quality, and Commercial teams, ensuring regulatory requirements for digital pathology solutions are proactively integrated throughout the product lifecycle,from development through commercialization and post-market activities.

The Regulatory Expert will act as a subject matter expert in digital pathology, withdeepunderstanding of global regulatory frameworks (, FDA, EU IVDR/MDR), software-driven diagnostics, and companion diagnostic applications. This role translates complex regulatory expectations into clear, practical strategies.

Key Responsibilities