Risk Management SME

Risk Management Remediation SMEWe 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 and responsibilities include:Advise on system-level assessment of the risk management framework to identify gaps related to risk integration, escalation, and decision-makingSupport the design and implementation of remediation actions to ensure risk information is consistently elevated, evaluated, and acted upon at appropriate governance levelsSupport the establishment of clear risk escalation pathways, thresholds, and triggers aligned with regulatory expectationsServe as SME for ISO 14971, ensuring alignment across policies, procedures, and executionEvaluate and remediate the application of ISO 14971 principles across design controls and post-market activitiesEnsure consistent interpretation and application of risk acceptability criteria, benefit-risk determinations, and residual risk evaluationsStrengthen integration of risk management outputs into Management Review, CAPA, change control, and other QMS decision-making processesDefine and remediate interfaces between risk management and other QMS elements, ensuring risk is a core input—not a standalone activitySupport the development of risk-based governance mechanisms, including dashboards, summaries, and executive-level risk reportingAssess and remediate how post-market signals (complaints, nonconformances, CAPAs, trends) are evaluated for risk impact and escalationEnsure post-market risk updates appropriately feed back into risk files, benefit-risk assessments, and system-level decisionsStrengthen linkages between post-market surveillance and design risk managementAlign remediation activities with FDA expectations and global regulatory standardsSupport regulatory interactions, audits, and follow-up related to risk management findingsEnsure documentation clearly demonstrates systemic correction and sustainable controls.Requirements:8+ years of experience in medical device risk managementDemonstrated leadership of risk management remediation efforts, particularly following regulatory findingsDeep, hands-on knowledge of ISO 14971 across design and post-market risk managementExperience implementing risk management systems that integrate with broader QMS governanceProven experience integrating risk management into executive decision-making, escalation frameworks, and QMS governanceAbility to translate complex risk data into clear, actionable insights for leadershipStrong understanding of FDA expectations for risk management and system-level controlsExperience supporting inspections, audits, and remediation related to risk findings