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Senior Regulatory Affairs Specialist - Medical Devices

Katalyst CRO

Katalyst CRO is seeking a Regulatory Affairs Senior Specialist to oversee global registrations and ensure regulatory compliance for medical devices, including Class I/II devices and software as a medical device. The role covers submissions, QMS alignment, and interpreting evolving standards across US, EU, and other regions. Ideal candidates hold a BS degree with 5–7 years in medical device regulatory affairs, strong ISO/FDA/EU MDR knowledge, Excel/database proficiency, and excellent #J-18808-Ljbffr Katalyst CRO

Vacancy posted 7 hours ago
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