WHOOP · 4 days ago
Director, Regulatory Affairs and Quality Assurance
Boston, MA
Full-time
Onsite
Director/Executive
$220K/yr - $245K/yr
8+ years expWHOOP is an advanced health and fitness wearable on a mission to unlock human performance and healthspan. The Director of Regulatory Affairs & Quality Assurance will lead the strategy and execution of WHOOP’s regulatory and quality frameworks, ensuring compliance across global markets and overseeing the development of medical device capabilities.
Consumer ElectronicsFitnessSportsWearablesWellness
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
Qualification
Required
Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field
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
Preferred
Advanced degree preferred
It is strongly preferred that the candidate is able to work out of the WHOOP office located in Boston, MA
Benefits
Competitive base salaries
Meaningful equity
Benefits
Generous equity package
Company
WHOOP
WHOOP is a fitness tech company that offers wearables that track sleep, recovery, and performance.
501-1000 employees
H1B Sponsorship
WHOOP has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (18)
2023 (15)
2022 (5)
2021 (17)
2020 (6)
Funding
Current Stage
Late StageTotal Funding
$404.75MKey Investors
SoftBank Vision FundIVPFoundry Group
2026-01-15Undisclosed
2021-08-30Series F· $200M
2020-10-28Series E· $100M
Leadership Team
Will Ahmed
Founder & CEO
Aurelian Nicolae
Co-Founder & Chief Hardware Engineer
Recent News
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-15
Company data provided by crunchbase