Sr Compliance Specialist - QA

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.

ATTENTION : Current Alcon Employee / Contingent Worker

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Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

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Skills Required

sscp, PMSR