Medical Device Risk Management Specialist
OR
Last updated on 05 Feb 2026
Overview
A Medical Device Risk Management Specialist ensures that medical devices meet global safety and compliance standards by identifying, assessing, and mitigating potential risks throughout the product lifecycle. They play a key role in safeguarding patient safety and product quality.

Job Description
- Develop and implement risk management processes according to ISO 14971 and relevant regulatory guidelines.
- Conduct risk assessments for medical devices during design, development, manufacturing, and post-market phases.
- Collaborate with cross-functional teams (R&D, Quality, Regulatory) to mitigate identified risks and implement effective controls.
- Prepare and maintain risk management files and documentation required for regulatory submissions and audits.
- Monitor post-market data and field feedback to continuously evaluate device safety and update risk management strategies.

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