Regulatory Affairs Coordinator Resume Examples & Tips for 2025

The Regulatory Affairs Coordinator plays a vital role in ensuring healthcare products and services maintain compliance with FDA regulations, international standards, and industry requirements through managing regulatory submissions, maintaining documentation, and coordinating with cross-functional teams. This position requires a Bachelor's degree in Life Sciences or related field, 2-3 years of regulatory experience in healthcare/medical devices, strong attention to detail, and excellent project management skills. As a key liaison between regulatory agencies and internal stakeholders, this role is essential for maintaining product compliance, facilitating timely approvals, and supporting the organization's commitment to quality and patient safety while navigating complex regulatory landscapes.