Principal Regulatory Affairs Specialist

Job Summary

Collaborating with cross-functional teams, the full-time Principal Regulatory Affairs Specialist will provide regulatory guidance, author submissions for medical devices, and monitor regulatory landscape changes while working remotely.

Key responsibilities

• Serve as the regulatory representative, providing guidance to product development and project teams
• Author US FDA premarket submissions and international submissions for medical devices, including software devices
• Maintain regulatory data, files, and daily operations while mentoring junior regulatory staff

Required qualifications

• Bachelor's degree in Engineering, Science, or a relevant technical discipline
• Minimum of nine years of Regulatory Affairs experience in a medically regulated environment
• At least seven years of experience in a medical device company (US FDA Class II)
• Two years of experience with software medical devices (SaMD, SiMD)
• Regulatory Affairs Certification (RAC) preferred