Whoop
Staff Regulatory Affairs Associate (Digital Health & AI Technologies)
Boston, MA · Staff+ · Full-time
Sponsorship not specified$170k-$220kDetected 5 days ago
AlgorithmsMachine LearningData ScienceLLMsFDA RegulatoryMedical DevicesLeadershipCommunicationRegulatory Affairs
About the role
- 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.
- 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.
Responsibilities
- Serve as the primary regulatory advisor to cross functional teams, providing guidance throughout concept development, feature design, model development, and validation
- Develop regulatory approaches for emerging technologies, such as foundation models, generative AI, and adaptive algorithms, where regulatory expectations are evolving and established pathways may not exist
- Support regulatory interactions with FDA reviewers, notified bodies, and other authorities to discuss innovative technologies, regulatory pathways, and product development strategies
- Communicate regulatory risks, opportunities, and strategic considerations to stakeholders and leadership to support informed product and development decisions
- Collaborate cross-functionally to develop scalable regulatory approaches that enable innovation while maintaining compliance and product quality
Requirements
- Demonstrated experience partnering directly with software engineering, product management, data science, or AI/ML teams to shape product development and regulatory strategy
- Strong understanding of intended use, claims strategy, risk classification, software functionality, software lifecycles, and clinical evidence considerations
- Ability to translate complex regulatory requirements into practical guidance for product, engineering, and business stakeholders
- Strong written and verbal communication skills, with the ability to clearly articulate regulatory strategy and recommendations to both technical and non-technical audiences
- The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.
- 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.
- Bachelor's degree in Regulatory Affairs, Engineering, Computer Science, or a related field. Advanced degree preferred
- 8+ years of Regulatory Affairs experience within the medical device industry
- Demonstrated experience developing regulatory strategies for Software as a Medical Device (SaMD), digital health products, wearable technologies, or AI/ML-enabled medical technologies
- Strong 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 interactions
- Working knowledge of international medical device regulations, particularly FDA and EU MDR frameworks
- Familiarity with AI/ML technologies, machine learning lifecycle concepts, foundation models, generative AI, and emerging regulatory approaches to artificial intelligence in healthcare
- Demonstrated success influencing cross-functional teams and operating effectively in fast-paced, highly innovative environments
Nice to have
- Bachelor's degree in Regulatory Affairs, Engineering, Computer Science, or a related field.
- Advanced degree preferred
Compensation
- 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.
Benefits
- 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.
- Develop and drive regulatory strategies for Software as a Medical Device (SaMD), AI/ML-enabled products, wearable technologies, and other digital health solutions
- Serve as an internal subject matter expert on FDA digital health policies, SaMD frameworks, AI/ML regulatory approaches, international regulations, and emerging industry trends
Company info
- At WHOOP, we're on a mission to unlock human performance and extend healthspan.
This listing is sourced directly from Whoop's careers page and normalized into a canonical job model.