Regulatory Affairs and Compliance Expert
5 days ago
We are looking for a Regulatory Affairs and Compliance Expert to join our team at Alcon.
In this role, you will be responsible for ensuring that our medical devices meet regulatory requirements and compliance standards.
Key Responsibilities:- Lead site validation, Computer System Validation (CSV), risk management activities, non-conformance investigations, change requests, document review & approvals, etc.
- Meet quality objectives set by management & comply with Alcon, QMS and Safety requirements.
- Establish and manage processes for Computer System Validation (CSV) & Non-Conformances, including training effectiveness and oversight on execution.
- Provide e-compliance oversight to site CSV activities, and provide guidance and coaching to CSV SMEs.
- Oversee all site validation activities, manufacturing projects, including laboratory equipment and method transfers, infrastructure, utilities and supporting functions.
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