Katalyst CRO
Global Medical Device Regulatory Affairs Specialist
Katalyst CRO, Richmond, Illinois, United States, 60071
A leading clinical research organization in the United States is seeking a Regulatory Affairs Level III (Senior Specialist) to ensure global product registrations and compliance in the medical device sector. The candidate will oversee regulatory strategies, prepare product registrations, and support audits and inspections. Ideal candidates will have a Bachelor of Science degree and 5-7 years of experience in regulatory affairs, specifically in medical devices such as respiratory devices. Strong analytical and communication skills are essential as well as knowledge of ISO and FDA standards.
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