Principal Regulatory Affairs

Job Summary

To support regulatory strategy and execution across the medical device product lifecycle, the full-time Principal Regulatory Affairs will develop regulatory strategies, provide guidance to cross-functional teams, and manage submissions while working remotely.

Key responsibilities

• Develop and support regulatory strategies for new products and lifecycle activities
• Provide regulatory guidance to cross-functional teams, balancing requirements and business needs
• Author and support FDA 510(k) submissions and EU MDR technical documentation

Required qualifications

• Bachelor's degree or higher in a scientific, engineering, regulatory, or related discipline
• 5+ years of relevant Regulatory Affairs experience, preferably in the medical device industry
• Experience with FDA and EU medical device regulatory requirements and submissions
• Strong project-management and organizational skills
• Ability to influence without direct authority and build effective cross-functional relationships