Principal Regulatory Affairs Specialist

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