Responsibilities:
In this role, you will work with the WHOOP Medical Device Team to act as a champion of Regulatory activities throughout the medical device lifecycle
As a Regulatory Affairs Manager, you will be responsible for various regulatory & quality functions, such as leading regulatory submissions, implementation of quality system processes, collaborating with the WHOOP Medical Device Team throughout the product development process, and ensuring compliance with the Quality Management System (QMS)
You will hold yourself and the team accountable for developing best-in-class, safe, and effective medical devices that address customer and regulatory requirements
Additionally, you will need to bring best practices and creative problem-solving abilities to support high-speed medical development in a consumer wearable company
Lead regulatory strategy and submissions for WHOOP's SaMD products, including FDA (k), ...