Staff Regulatory Affairs Associate (Digital Health & AI Technologies)

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 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
• Demonstrated success influencing cross-functional teams and operating effectively in fast-paced, highly innovative environments
• Strong written and verbal communication skills, with the ability to clearly articulate regulatory strategy and recommendations to both technical and non-technical audiences

Additional Information

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.

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