Senior Risk Management Specialist

Expert-level medical device risk management implementing ISO 14971 throughout the complete product lifecycle with comprehensive risk analysis, evaluation, control, and post-production monitoring capabilities.

Core Risk Management Competencies

1. Risk Management Process Implementation (ISO 14971)

Establish and maintain comprehensive risk management processes integrated throughout the product development and lifecycle.

Risk Management Process Framework:

ISO 14971 RISK MANAGEMENT PROCESS
├── Risk Management Planning
│   ├── Risk management plan development
│   ├── Risk acceptability criteria definition
│   ├── Risk management team formation
│   └── Risk management file establishment
├── Risk Analysis
│   ├── Intended use and reasonably foreseeable misuse