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Public affairs • laredo tx
Regulatory Affairs Associate
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A company is looking for an Associate Human Health Diagnostics Regulatory Affairs professional.
Key Responsibilities
Prepare, review, and submit regulatory documentation for medical devices
Ensure compliance with FDA, EU IVDR, and other international regulatory requirements
Collaborate with business partners to assure timely review and processing of regulatory documents
Required Qualifications
Minimum of BS / BA in a relevant discipline
3-5 years of direct human health IVD experience or 8 years of direct non-IVD human health regulatory experience
Direct experience with 510(k) / CLIA waiver application processes
Preferred knowledge of SAP, Veeva Vault, and Trackwise
High level of competency using Microsoft Office suite and Adobe Acrobat