•  Reviews and approves documentation including but not limited to:
•  Reviewing, commenting and/or approving documents associated with the Clinical Evaluation Report 
in support of EU regulatory submissions or DOC, aggregate reports, PMCF-P,
PMCF-R, PMSP, PMSR, PSURs and SSCP.
•  Attend project meetings as primary point of contact for Clinical QA. Provide input and feedback 
on Clinical Evaluation documentation and clarity on the compliance requirements.
•  Maintains and tracks CQA review and approval deliverables for each project based on project 
plans.

•  Supports preparation of metrics and trends, interprets and presents compliance data per EUMDR 
and Alcon standards

•  Ensures senior management awareness of compliance issues impacting regulatory acceptability, by 
appropriately escalating as per quality risk management. Provides support to relevant functions on 
proper identification and escalation of quality related issues.
•  Provides support for audit preparation, collaborate in remediation as needed, for both national 
and local inspections (e.g., TUV Notified Body etc.)
•  Provides support or assist on other tasks as assigned.
 

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