Risk Management SME

Job-ID Reference
26-01121

Remote
50% Remote

Summary:

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.

Roles & responsibilities:

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.

Requirements: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 Regulatory Strong understanding of FDA expectations for risk management and system-level controls

Experience supporting inspections, audits, and remediation related to risk findings Key