Risk Management Specialist (ISO 14971)

Job Summary

To support critical regulatory initiatives, the contract Risk Management SME (ISO 14971) will lead system-level risk management remediation, strengthen QMS integration, and ensure alignment with regulatory standards in the medical devices sector.

Key Responsibilities

• Lead system-level risk management remediation and gap assessments
• Strengthen risk integration into QMS and governance frameworks
• Assist in regulatory audits, FDA interactions, and inspection readiness

Required Qualifications

• 10+ years in medical device risk management
• Strong expertise in ISO 14971 (design + post-market)
• Proven experience in remediation following regulatory findings
• Deep understanding of FDA expectations and QMS integration
• Ability to present risk insights to leadership and drive decisions