Senior Regulatory Affairs Manager

Regulatory Affairs Manager

In this role, you will work with the WHOOP Medical Device Team to act as a champion of U.S. 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 U.S. regulatory strategy and submissions for WHOOP's SaMD products, including FDA 510(k), De Novo classification requests, and pre-submission meetings. Prepare and submit U.S. regulatory documentation including Q-submissions, De Novo requests, 510(k)s, product change notifications, and post-market reports. Serve as U.S. regulatory lead on cross-functional teams, advising on design controls, labeling, software documentation, risk management, clinical evaluations, and usability. Mentor teammates and evangelize U.S. regulatory strategy within WHOOP. Support development and maintenance of WHOOP's FDA-compliant QMS, ensuring adherence to 21 CFR 820 and ISO 13485:2016. 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 U.S. medical device requirements. Monitor changes in the U.S. 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.

Bachelor's Degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or related field, or equivalent practical experience. 5+ years of experience in regulatory affairs and quality management systems for medical device software. Comprehensive knowledge of global regulatory requirements for SaMD products. Strong understanding of ISO 13485 and other quality management system standards. Proven experience in successful product registrations and market clearances in multiple countries. Excellent organizational, interpersonal, verbal, and written communication skills. Passion for delivering impactful and high-quality products to people. Experience with Consumer Wearable Products, General Wellness Products, Digital Health or Mobile Medical Applications is a plus. Experience with Machine Learning medical device technologies in an ambiguous, fast-paced, and innovative environment is a plus. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.