Principal Regulatory Affairs Specialist - Software Devices

Principal Regulatory Affairs Specialist supporting product development and regulatory compliance for medical devices at Treace Medical. Role involves authoring FDA premarket submissions, managing agency interactions, and monitoring regulatory landscape changes across software and traditional device categories.

Responsibilities

• Author US FDA premarket submissions (510(k), Q-submissions) and international submissions for medical devices
• Serve as primary regulatory agency contact for assigned submissions and negotiate requirements with authorities
• Monitor regulatory landscape changes and assess impact on company processes and guidance
• Review advertising, promotional materials, and product labeling with Marketing, Sales, Legal partners
• Mentor junior regulatory staff and develop training on regulatory requirements and procedures

Requirements

• Bachelor's degree in Engineering, Science, or relevant technical discipline
• Minimum 9 years regulatory affairs experience in medically regulated environments
• At least 7 years experience in medical device company (US FDA Class II)
• 2+ years software medical device (SaMD, SiMD) experience
• RAC certification through RAPS preferred