Regulatory Affairs Associate

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