Regulatory Affairs Manager

At WHOOP, we're on a mission to unlock human performance and healthspan. WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives.WHOOP is seeking a Regulatory Affairs Manager (Medical Devices) to navigate and manage regulatory affairs for Medical Device Software in the US. 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. RESPONSIBILITIES:Lead U.S. regulatory strategy and submissions for WHOOP’s SaMD products, including FDA 510(k), De Novo classification requests, and pre-submission meetingsPrepare and submit U.S. regulatory documentation including Q-submissions, De Novo requests, 510(k)s, product change notifications, and post-market reportsServe as U.S. regulatory lead on cross-functional teams, advising on design controls, labeling, software documentation, risk management, clinical evaluations, and usabilityMentor teammates and evangelize U.S. regulatory strategy within WHOOPSupport development and maintenance of WHOOP’s FDA-compliant QMS, ensuring adherence to 21 CFR 820 and ISO 13485:2016Support internal audits, supplier audits, and FDA inspections or third-party audits as neededImplement post-market surveillance, including complaint handling, adverse event reporting (MDR), and field actionsDevelop and implement training programs to strengthen company-wide awareness of U.S. medical device requirementsMonitor changes in the U.S. FDA guidance, enforcement trends, and relevant standardsFoster strong partnerships across Product, Legal, and Engineering to balance speed and compliance in bringing impactful health technologies to marketQUALIFICATIONS:Bachelor’s Degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or related field, or equivalent practical experience5+ years of experience in regulatory affairs and quality management systems for medical device softwareComprehensive knowledge of global regulatory requirements for SaMD productsStrong understanding of ISO 13485 and other quality management system standardsProven experience in successful product registrations and market clearances in multiple countriesExcellent organizational, interpersonal, verbal, and written communication skillsPassion for delivering impactful and high-quality products to peopleNice to Have: Experience with Consumer Wearable Products, General Wellness Products, Digital Health or Mobile Medical ApplicationsNice to Have: Experience with Machine Learning medical device technologies in an ambiguous, fast-paced, and innovative environmentThis role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA terested in the role, but don’t meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr

Created: 2025-09-17