Applies product, clinical, regulatory and standards knowledge to legacy DHF/RMF remediation. |
Reviews available user needs and intended-use documentation for completeness and consistency. |
Checks traceability among user needs, design inputs, outputs and supporting verification/validation evidence; documents gaps for remediation. |
Reviews design rationale and supporting records; updates documentation to address identified gaps. |
Identifies and coordinates retrieval of objective evidence needed to complete DHF/RMF records. |
Coordinates with cross-functional teams to locate and assess design verification, validation and process-validation evidence. |
Reviews production specifications and inspection records for completeness and consistency with design documentation. |
Links critical-to-quality features and inspection evidence to applicable design requirements and risks. |
Reviews design verification, validation and risk-control evidence against requirements and applicable procedures. |
Partners with Quality, Regulatory, Manufacturing and Sourcing to resolve documentation gaps and obtain approvals. |
Assesses test-method documentation and supporting evidence; identifies gaps requiring follow-up. |
Authors, reviews and routes DHF/RMF remediation updates for cross-functional approval under applicable procedures. |
Provides DHF/RMF evidence to support regulatory submissions and inquiries, as assigned. |
Coordinates review of relevant clinical evidence for completeness and alignment with design and risk records. |
Supports Quality and Post-Market Surveillance investigations by reviewing related design and risk records. |
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Maintains remediation plans, timelines and status; communicates progress to stakeholders. |
Escalates resource needs, blockers and overdue remediation actions. |
Coordinates cross-functional remediation reviews as needed. |
Tracks action owners, deliverables and due dates through closure. |
Reports remediation status and unresolved issues to leadership. |
Identifies remediation risks, agrees mitigations with stakeholders and escalates issues requiring direction. |
