What are the responsibilities and job description for the Risk Management Remediation Lead position at Medical Devices Manufacturing?
Risk Management Lead - Onsite Delaware
Risk Management Remediation Lead – Medical Device (ISO 14971)
- Lead system-level risk management remediation initiatives to address gaps in risk integration, escalation, and decision-making.
- Serve as SME for ISO 14971, ensuring proper application of risk management across design controls and post-market activities.
- Assess and strengthen risk management frameworks, including risk acceptability, benefit-risk analysis, and residual risk evaluation.
- Integrate risk outputs into QMS processes such as CAPA, Change Control, and Management Review.
- Evaluate post-market signals (complaints, nonconformances, CAPAs, trend data) and ensure risk updates feed back into risk files and benefit-risk assessments.
- Develop and manage risk remediation plans, timelines, and cross-functional execution.
- Establish risk escalation pathways, dashboards, and executive-level reporting mechanisms.
- Ensure remediation outputs are inspection-ready and aligned with FDA expectations and global regulatory standards.
- Support regulatory audits, inspections, and responses related to risk management findings.
Thanks,
Sneha Pasala
Senior Recruiting Specialist
1 (972) 633 6387
sneha.p@ndgcs.com