Risk Manager (San Fernando de Henares)

Position Overview

The Risk Manager reports to the R&D Director and is responsible for maintaining risk management activities for legacy devices and supporting new product development activities. The role contributes directly to regulatory submissions and launch timelines for medical devices and aesthetic products.

Responsibilities

• Lead and coordinate all risk management activities in accordance with ISO 14971, ISO 13485, MDR, and Annex XVI.
• Plan, prepare, and perform risk management for medical devices and aesthetic products throughout project phases, following internal procedures, processes, and external requirements.
• Represent risk management on assigned development projects.
• Establish risk acceptance criteria for individual residual risks and the overall residual risk for devices in development and legacy devices.
• Maintain close collaboration with the Human Factors/Usability Engineering process to ensure safety ...