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 solutions
Serve as the primary regulatory advisor to cross functional teams, providing guidance throughout concept development, feature design, model development, and validation
Partner 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 strategies
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
Serve as an internal subject matter expert on FDA digital health policies, SaMD frameworks, AI/ML regulatory approaches, international regulations, and emerging industry trends
Support regulatory interactions with FDA reviewers, notified bodies, and other authorities to discuss innovative technologies, regulatory pathways, and product development strategies
Provide strategic leadership and input for FDA and EU submissions, including Q-Submissions, 510(k)s, De Novo requests, EU MDR technical documentation
Monitor 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 technologies
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
QUALIFICATIONS:
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
Skills Required
- Bachelor's degree in Regulatory Affairs, Engineering, Computer Science, or related field
- Advanced degree
- 8+ years Regulatory Affairs experience within the medical device industry
- Experience developing regulatory strategies for SaMD, digital health, wearable technologies, or AI/ML-enabled medical technologies
- Experience supporting or leading Q-Submissions, 510(k)s, De Novo submissions or similar regulatory interactions
- Working knowledge of FDA and EU MDR regulatory frameworks and international medical device regulations
- Familiarity with AI/ML technologies, foundation models, generative AI, adaptive algorithms, and ML lifecycle concepts
- Experience partnering with software engineering, product management, data science, or AI/ML teams
- Strong understanding of intended use, claims strategy, risk classification, software lifecycles, and clinical evidence considerations
- Ability to translate complex regulatory requirements into practical guidance and influence cross-functional teams
- Strong written and verbal communication skills
What the Team is Saying
.jpg)
.jpg)
WHOOP Compensation & Benefits Highlights
-
Wellbeing & Lifestyle Benefits — Wellness support includes a stipend and a complimentary WHOOP membership to use and gift, aligning perks with the company’s health focus. Feedback suggests these lifestyle benefits are a meaningful part of total rewards.
-
Healthcare Strength — Core coverage spans medical, dental, vision, mental health services, and life and disability insurance. This breadth indicates a comprehensive health safety net.
-
Equity Value & Accessibility — Total rewards commonly include stock options or equity participation, positioning ownership as part of compensation. Feedback suggests equity is viewed as a valuable component of the package.
WHOOP Insights
What We Do
At WHOOP, we’re on a mission to unlock human performance. WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives. Our wearable device and performance optimization platform has been adopted by many of the world's greatest athletes and consumers alike.
Why Work With Us
At WHOOP, we’re focused on building an inclusive and equitable team with a strong sense of belonging for everyone—increasing representation in every way as our team grows. We believe that our differences are our source of strength—so much so it’s one of our core values.
Gallery
WHOOP Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
