About the role

Director of Regulatory Affairs & Quality Assurance at WHOOP managing regulatory frameworks for health technology. Shaping regulatory pathways and ensuring compliance across global markets.

Responsibilities

Lead regulatory strategy for WHOOP’s health features and regulated products from development through approval and lifecycle management.
Oversee regulatory submissions including 510(k), De Novo, technical files, global registrations, providing strategic direction, final review, and cross-functional alignment.
Serve as WHOOP’s primary liaison with regulatory agencies and notified bodies.
Interpret and communicate regulatory requirements to cross-functional teams, ensuring seamless integration throughout the development lifecycle.
Oversee WHOOP’s Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, MDR, and other global regulatory frameworks.
Provide leadership and oversight for Design Quality Engineers responsible for DHF maintenance, design reviews, risk management (ISO 14971), verification/validation strategy, and software change control processes.
Lead internal and external audit readiness, including FDA inspections and notified body audits.
Manage post-market surveillance and adverse event reporting.
Review marketing and promotional materials for regulated and general wellness features to ensure compliance.
Build, manage, and mentor a high-performing team.
Monitor regulatory changes, evolving standards, and industry trends, advising leadership on implications and opportunities.

Bachelor’s degree in life sciences, engineering, regulatory affairs, or a related field; advanced degree preferred.
8+ years of regulatory affairs experience in medical devices, digital health, wearables, or related fields.
Proven experience leading successful FDA submissions (510(k), De Novo) and managing global regulatory approvals.
Demonstrated success building or overseeing a Quality Management System, including experience with external audits.
Deep understanding of software as a medical device (SaMD), cybersecurity considerations, post-market requirements, and applicable standards.
Strong working knowledge of ISO 14971 risk management, including hazard analysis, FMEAs, risk/benefit justification, and integration of risk controls across hardware, firmware, and software.
Experience overseeing post-market quality activities, including complaints, MDR/Vigilance assessments, field actions, and design updates based on post-market signals.
Working knowledge of privacy and data regulations such as HIPAA and GDPR.
Exceptional communication, leadership, and stakeholder management skills.
Ability to thrive in a fast-paced, high-growth environment with evolving priorities.
Experience navigating the boundary between general wellness and SaMD, including evaluating feature intent, regulatory risk, and appropriate evidence pathways.