Job Summary
The role focuses on overseeing risk management post-commercialization and leveraging data-driven safety analytics. The expert will be responsible for maintaining risk files compliant with ISO 14971 and constructing comprehensive global post-market surveillance strategies. This position requires in-depth analysis of product-use data in collaboration with cross-functional teams, conveying actionable recommendations to leadership, and promoting risk mitigation as well as continual enhancement throughout the product lifecycle.
Responsibilities
- Lead the management of post-commercialization risks through effective data analysis.
- Ensure compliance with ISO 14971 in maintaining risk documentation.
- Develop and implement global post-market surveillance plans.
- Collaborate with cross-functional teams to analyze and interpret product-use data.
- Communicate insights and actionable findings to leadership effectively.
- Drive initiatives for risk remediation and continuous product improvement.
Qualifications
- Bachelor’s degree in engineering, ideally in software engineering, plus a related master’s degree or equivalent experience.
- At least five years of experience in medical device risk management.
- Knowledge of FDA, EU MDR, IMDRF, ISO standards, and quality system regulations.
- Proficiency in statistical analysis tools.
- Strong project management abilities and excellent communication skills.
