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.
NeuroPace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
