Risk Management SME

Karwell Technologies

Branchburg, NJ

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JOB DETAILS

SKILLS

Change Control, Corrective and Preventative Action (CAPA) Systems, Documentation, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Leadership, Medical Equipment, Regulations, Reporting Dashboards, Risk, Risk Analysis, Risk Management, Risk Management Framework (RMF), Surveillance, System Integration (SI), Systems Analysis, Trend Analysis

LOCATION

Branchburg, NJ

POSTED

9 days ago

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 RegulatoryStrong understanding of FDA expectations for risk management and system-level controls
Experience supporting inspections, audits, and remediation related to risk findings Key

About the Company

Karwell Technologies

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