Senior Regulatory Affairs Specialist

AtriCure seeks a Senior Regulatory Affairs Specialist to prepare and submit regulatory submissions for medical devices across US and international markets. The role involves developing regulatory strategies, managing 510(k) and PMA applications, and supporting new product development initiatives.

Responsibilities

• Develop written regulatory strategies for new product development and sustaining projects
• Prepare and submit US regulatory applications including 510(k)s, PMAs, and supplements
• Manage international regulatory submissions and notifications across multiple markets
• Serve as regulatory representative on cross-functional new product development teams

Requirements

• Extensive experience preparing FDA 510(k), PMA, and PMA supplement submissions
• Knowledge of international regulatory requirements for EU, Canada, Australia, Brazil, Japan
• Strong technical writing and documentation skills for regulatory submissions
• Familiarity with medical device design control and post-market compliance processes
• Experience in cardiovascular or electrophysiology device sector preferred