Risk Management Process Lead

Job Summary

A company is looking for a Global Risk Management Process Lead.

Key Responsibilities

• Develop and maintain global risk management procedures and tools in compliance with ISO standards
• Ensure risk management is integrated throughout the product lifecycle and maintain Risk Management Files
• Facilitate audits and prepare documentation for regulatory submissions

Required Qualifications

• Bachelor's degree in Biomedical, Mechanical, Systems Engineering or related field
• 8+ years of relevant work experience or equivalent combination of education and experience
• Certification in Risk Management is highly desirable
• Advanced knowledge of regulatory standards such as ISO 14971 and FDA regulations
• Experience in simplifying risk management processes and documentation