Staff Regulatory Affairs Associate (Digital Health & AI Technologies)

Whoop

Boston, US

Who this role is best for

Aimed at senior regulatory professionals who navigate emerging digital health and AI technologies within a Boston-based innovation environment.

Best fit for

Regulatory strategists comfortable with AI and digital health frontier technologies
— “regulatory strategy for next-generation digital health, Software as a Medical Device (SaMD), and AI-enabled technologies”
Professionals experienced in risk assessment for novel medical software products
— “assess risks and opportunities, and provide strategic guidance within a rapidly evolving regulatory environment”
Individuals who bridge technical innovation with compliance requirements
— “operate at the intersection of product innovation, software development, artificial intelligence, and regulatory affairs”

Things to consider

Focus on rapidly evolving regulatory landscapes for digital health technologies
— “rapidly evolving regulatory environment”
Expect involvement in pioneering unestablished regulatory pathways for novel technologies
— “exploring novel technologies could redefine how health insights are delivered and regulated”

How to stand out

Demonstrate concrete examples of shaping regulatory strategy for AI health products
— “help shape the regulatory strategy for next-generation digital health”
Highlight experience with both established frameworks and emerging compliance challenges
— “ensuring compliance with applicable regulations”

Pace · SteadyCollaboration · HighAutonomy · MediumDecision Impact · CompanyLevel · Senior

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

shaping regulatory strategy for digital health technologies
defining regulatory pathways
assessing risks and opportunities

Typical background

regulatory affairs experienceknowledge of digital health regulations

Skills & requirements

Required

Regulatory AffairsDigital HealthAI TechnologiesSoftware As A Medical Device (samd)Regulatory Strategy

Preferred

Novel TechnologiesRisk Assessment

Stack & domain

Regulatory StrategyDigital HealthSoftware As A Medical Device (samd)Ai-enabled TechnologiesContinuous Physiological MonitoringAdvanced AnalyticsIntelligent SoftwareHealthPerformanceRecoveryLong-term Health

About the role

Original posting from Whoop via Lever

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.

Source: Whoop careers (Lever)