
Impactful Regulatory Affairs Associate — Medical Devices
Katalyst CRO, Boulder, Colorado, United States, 80301
A medical device regulatory firm is seeking an Associate Regulatory Affairs Manager to support the development, review, and submission of regulatory documents for medical devices and IVD products. The position requires collaboration with cross-functional teams to ensure compliance with FDA and ISO regulations. Candidates should hold a bachelor's degree and possess 4-6 years of regulatory experience, particularly with 510(k) submissions. Strong organizational skills and the ability to manage multiple projects are essential.
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