Description

You will execute global regulatory strategies for AI/ML-enabled medical devices, preparing submissions for US, Europe, Canada, and other markets. Collaborate with cross-functional teams to integrate regulatory requirements into product development and ensure ongoing compliance.

Requirements

• Strong technical writing and submission experience
• Knowledge of global regulations for medical devices (SaMD, AI/ML)

Responsibilities

• Execute global regulatory strategies for AI/ML medical devices
• Prepare and manage regulatory submissions across multiple regions
• Support interactions with regulatory authorities
• Ensure alignment with SaMD and AI/ML regulatory requirements
• Provide practical regulatory guidance to product teams