Katalyst CRO
Global Regulatory Affairs Specialist — Medical Devices
Katalyst CRO, Chicago, Illinois, United States
A leading clinical research organization is seeking a Regulatory Affairs Specialist to oversee global product registrations and ensure compliance for medical devices. The ideal candidate has 5-7 years of regulatory experience, in-depth knowledge of ISO standards, and exceptional analytical skills. Responsibilities include obtaining regulatory approvals, preparing submissions, and leading quality management initiatives. Strong communication skills are essential for articulating complex regulatory issues. This role offers an opportunity to contribute to innovative medical solutions while ensuring adherence to stringent regulatory standards.
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