Senior Regulatory Affairs Specialist
About this role
About the Role The Senior Regulatory Affairs Specialist is responsible for supporting global regulatory compliance of Medical Devices placed on the market by Cytiva. This on-site role in Kraków, Poland, is part of Medical Regulatory Affairs and will help advance regulatory readiness and compliance across the product lifecycle. What You'll Do
- Manage assessments related to product change control and updates to applicable ISO standards, including monitoring of follow up actions to ensure ongoing regulatory compliance for medical devices.
- Oversee global processes related to regulatory activities, specifically regulatory assessment of medical device product complaints and supply disruption reporting.
- Provision of high-quality customer requests for regulatory information.
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