Regulatory Affairs Manager

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), De Novo classification requests, and pre-submission meetings.
• Prepare and submit regulatory documentation including Q-submissions, De Novo requests, (k)s, product change notifications, and post-market reports.
• Serve as regulatory lead on cross-functional teams, advising on design controls, labeling, software documentation, risk management, clinical evaluations, and usability.
• Mentor teammates and evangelize regulatory strategy within WHOOP.
• Support development and maintenance of WHOOP's FDA-compliant QMS, ensuring adherence to CFR and ISO : .
• Support internal audits, supplier audits, and FDA inspections or third-party audits as needed.
• Implement post-market surveillance, including complaint handling, adverse event reporting (MDR), and field actions.
• Develop and implement training programs to strengthen company-wide awareness of medical device requirements.
• Monitor changes in the
• FDA guidance, enforcement trends, and relevant standards.
• Foster strong partnerships across Product, Legal, and Engineering to balance speed and compliance in bringing impactful health technologies to market.

Requirements :