Global Regulatory Affairs Lead – Medical Devices

AtriCure, Inc. seeks a Senior Regulatory Affairs Specialist to prepare and submit regulatory documents (510(k), PMA, EU/Canada/Japan) to support worldwide marketing.

You will serve on project teams for new products, ensure design control compliance, and liaise with FDA, EU Notified Bodies, Health Canada, and other agencies.

Requirements: Bachelor’s degree, 4+ years in medical device regulatory affairs, strong writing and communication skills; travel 10–15%.