KH
Risk Management SME
Katalyst Healthcares & Life Sciences
🇺🇸 United States
Hybrid
Mid level
3 months ago
- Risk Management
- Risk Management Framework
- CAPA
3 months ago
- We are seeking an experienced Risk Management Remediation SME to support system level remediation initiatives addressing identified gaps in risk management integration, decision-making, and escalation. This role will be critical in strengthening how risk is assessed, communicated, and acted upon across the organization, with a particular focus on integrating risk outputs into system-level governance and leadership decisions.
- The ideal candidate will bring deep expertise in ISO 14971, spanning both design-phase risk management and post-market risk activities, and have demonstrated experience remediating risk management systems in response to regulatory findings.
- Scope of Responsibility System-Level Risk Management Remediation
- Advise on system-level assessment of the risk management framework to identify gaps related to risk integration, escalation, and decision-making
- Support the design and implementation of remediation actions to ensure risk information is consistently elevated, evaluated, and acted upon at appropriate governance levels
- Support the establishment of clear risk escalation pathways, thresholds, and triggers aligned with regulatory expectations
- ISO 14971 Subject Matter Expertise
- Serve as SME for ISO 14971, ensuring alignment across policies, procedures, and execution
- Evaluate and remediate the application of ISO 14971 principles across design controls and post-market activities
- Ensure consistent interpretation and application of risk acceptability criteria, benefit-risk determinations, and residual risk evaluations
- Risk Integration & Governance
- Strengthen integration of risk management outputs into Management Review, CAPA, change control, and other QMS decision-making processes
- Define and remediate interfaces between risk management and other QMS elements, ensuring risk is a core input—not a standalone activity
- Support the development of risk-based governance mechanisms, including dashboards, summaries, and executive-level risk reporting
- Post-Market Risk Management
- Assess and remediate how post-market signals (complaints, nonconformances, CAPAs, trends) are evaluated for risk impact and escalation
- Ensure post-market risk updates appropriately feed back into risk files, benefit-risk assessments, and system-level decisions
- Strengthen linkages between post-market surveillance and design risk management
- Regulatory Readiness & Inspection Support
- Align remediation activities with FDA expectations and global regulatory standards
- Support regulatory interactions, audits, and follow-up related to risk management findings
- Ensure documentation clearly demonstrates systemic correction and sustainable controls.
- 8+ years of experience in medical device risk management
- Demonstrated leadership of risk management remediation efforts, particularly following regulatory findings ISO 14971 Expertise:
- Deep, hands-on knowledge of ISO 14971 across design and post-market risk management
- Experience implementing risk management systems that integrate with broader QMS governance
- Proven experience integrating risk management into executive decision-making, escalation frameworks, and QMS governance
- Ability to translate complex risk data into clear, actionable insights for leadership RegulatoryStrong understanding of FDA expectations for risk management and system-level controls
- Experience supporting inspections, audits, and remediation related to risk findings Key
Risk Management SME · Katalyst Healthcares & Life Sciences