Quality Systems & Regulatory Affairs Manager - Whoop

At WHOOP, we're on a mission to unlock human performance. WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives.

WHOOP is seeking a Quality Systems & Regulatory Affairs Manager (Medical Devices) to navigate and manage regulatory and quality system processes for Medical Device Software. In this role, you will work with the WHOOP Medical Device Team to act as a champion of Quality Systems and Regulatory activities throughout the medical device lifecycle.

As a Quality Systems & Regulatory Affairs Manager, you will be responsible for various regulatory & quality functions, such as leading regulatory submissions, implementation of quality system post-market 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.

Last updated: 19 hours ago

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