Compliance and Risk Specialist
3 days ago
About the Position
We are looking for a talented professional to join our team as a Compliance and Risk Specialist. The successful candidate will be responsible for ensuring compliance with regulatory requirements and identifying potential quality risks.
Key Responsibilities
- Regulatory Compliance
Ensure compliance with ISO 13485, FDA QSR, and MDR regulations.
Review and update quality procedures to reflect changes in regulatory requirements.
Quality Risk ManagementIdentify potential quality risks and develop strategies to mitigate them.
Provide regular reports to senior leadership on quality risks and their mitigation status.
Audit Planning and ExecutionPlan and conduct internal audits to identify areas for improvement.
Implement corrective actions to address audit findings.
Document ControlMaintain accurate and up-to-date records of quality documents.
Control access to sensitive quality information.
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