Staff Regulatory Affairs Associate (Digital Health & AI Technologies)

At WHOOP, we're on a mission to unlock human performance and extend healthspan. As the leader in wearable health and performance technology, WHOOP empowers millions of members with personalized insights derived from continuous physiological monitoring, advanced analytics, and cutting-edge software experiences.WHOOP is pioneering the future of wearable health technology by combining continuous physiological monitoring, advanced analytics, and intelligent software to help millions of members improve performance, recovery, and long-term health. As we expand into new areas of digital health and Software as a Medical Device (SaMD), we are exploring novel technologies could redefine how health insights are delivered and regulated.WHOOP is seeking a Staff Regulatory Affairs Associate to help shape the regulatory strategy for next-generation digital health, Software as a Medical Device (SaMD), and AI-enabled technologies. In this role, you will evaluate novel technologies, define regulatory pathways, assess risks and opportunities, and provide strategic guidance within a rapidly evolving regulatory environment. You will operate at the intersection of product innovation, software development, artificial intelligence, and regulatory affairs, helping shape the future of digital health while ensuring compliance with applicable regulations.RESPONSIBILITIES: Develop and drive regulatory strategies for Software as a Medical Device (SaMD), AI/ML-enabled products, wearable technologies, and other digital health solutionsServe as the primary regulatory advisor to cross functional teams, providing guidance throughout concept development, feature design, model development, and validationPartner with Product, Engineering, and AI/ML teams to evaluate regulatory implications of new features, algorithms, health insights, claims, intended uses, and user experiences, and recommend appropriate regulatory and claims strategiesDevelop regulatory approaches for emerging technologies, such as foundation models, generative AI, and adaptive algorithms, where regulatory expectations are evolving and established pathways may not existServe as an internal subject matter expert on FDA digital health policies, SaMD frameworks, AI/ML regulatory approaches, international regulations, and emerging industry trendsSupport regulatory interactions with FDA reviewers, notified bodies, and other authorities to discuss innovative technologies, regulatory pathways, and product development strategiesProvide strategic leadership and input for FDA and EU submissions, including Q-Submissions, 510(k)s, De Novo requests, EU MDR technical documentationMonitor and interpret evolving requirements, guidance documents, and standards related to digital health, AI/ML technologies, software lifecycle processes, Predetermined Change Control Plans (PCCPs), and emerging technologiesCommunicate regulatory risks, opportunities, and strategic considerations to stakeholders and leadership to support informed product and development decisionsCollaborate cross-functionally to develop scalable regulatory approaches that enable innovation while maintaining compliance and product qualityQUALIFICATIONS: Bachelor’s degree in Regulatory Affairs, Engineering, Computer Science, or a related field. Advanced degree preferred8+ years of Regulatory Affairs experience within the medical device industryDemonstrated experience developing regulatory strategies for Software as a Medical Device (SaMD), digital health products, wearable technologies, or AI/ML-enabled medical technologiesStrong understanding of FDA medical device regulations, regulatory pathways, and submission processes, including experience supporting or leading Q-Submissions, 510(k)s, De Novo submissions, or related regulatory interactionsWorking knowledge of international medical device regulations, particularly FDA and EU MDR frameworksFamiliarity with AI/ML technologies, machine learning lifecycle concepts, foundation models, generative AI, and emerging regulatory approaches to artificial intelligence in healthcareDemonstrated experience partnering directly with software engineering, product management, data science, or AI/ML teams to shape product development and regulatory strategyStrong understanding of intended use, claims strategy, risk classification, software functionality, software lifecycles, and clinical evidence considerationsAbility to translate complex regulatory requirements into practical guidance for product, engineering, and business stakeholdersDemonstrated success influencing cross-functional teams and operating effectively in fast-paced, highly innovative environmentsStrong written and verbal communication skills, with the ability to clearly articulate regulatory strategy and recommendations to both technical and non-technical audiencesThis 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 office.Interested 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.The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values.At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company’s long-term growth and success.The U.S. base salary range for this full-time position is $170,000 - $220,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training. In addition to the base salary, the successful candidate will also receive benefits and a generous equity package.These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate’s specific qualifications, expertise, and alignment with the role’s requirements.