Principal Regulatory Affairs Specialist - Software Devices

POSITION SUMMARY:

The Principal Regulatory Affairs Specialist will report to the Director of Regulatory Affairs and will work with Product Development, Quality, Operations, and Marketing to support the product development process and meeting all applicable regulatory requirements. The Principal Regulatory Affairs Specialist will work with Marketing, Sales, Legal and Regulatory partners on advertising and promotional materials as well as product labeling while meeting all applicable regulatory requirements. The Principal Regulatory Affairs Specialist will support daily regulatory operations and regulatory data management as well as monitor and assess applicable regulatory landscape changes.