WHOOP · 3 days ago
Quality Systems & Regulatory Affairs Specialist, Digital Health
Boston, MA
Full-time
Onsite
Mid, Senior Level
$144K/yr - $197K/yr
4+ years expWHOOP is on a mission to unlock human performance and health span, and they are seeking a Regulatory Affairs & Quality Systems Specialist to join their Digital Health team. In this role, you will execute regulatory strategy and support quality management system maintenance for WHOOP's software as a medical device (SAMD) products.
Consumer ElectronicsFitnessSportsWearablesWellness
Responsibilities
Support and submit U.S. regulatory documentation including Q-submissions, De Novo requests, 510(k)s, product change notifications, and post-market reports
Interpret international regulatory and quality requirements for medical devices across key markets
Create detailed regulatory and quality deliverables for global distribution of medical devices in countries such as Canada, Japan, EU, Brazil, and others
Prepare regulatory submissions for medical devices and maintain regulatory clearance throughout the product lifecycle
Interface with internal stakeholders such as engineering, product, and clinical teams to ensure regulatory and quality considerations are communicated throughout the product development lifecycle
Support internal audits, gap assessments, and procedural updates for compliance with ISO 13485, IEC 62304, EU MDR, and MDSAP requirements
Support maintenance and continuous improvement of the quality management system
Support regulatory assessments of post-market changes and reportable events.Support and lead internal and external audit activities to maintain QMS certifications
Qualification
Required
Bachelor's Degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or related field, or equivalent practical experience
At least 4 years of experience in the medical device industry with regulatory submission experience, specifically in Brazil, Mexico, Japan and South Korea
Strong written, oral, organization, problem solving, and interpersonal skills to effectively compose regulatory submissions, support audit backrooms, and complete assignments with minimal supervision
Demonstrated history in achieving regulatory market authorization
Knowledge and experience with Software as a Medical Device, Cybersecurity, Verification & Validation, and global Digital Health policy
Demonstrated experience in and working knowledge of medical device regulations and standards (ISO 13485, MDSAP etc)
Passion for delivering impactful and high-quality products to people
Preferred
Experience with AI/ML is a plus
Benefits
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
2021-08-30Series F· $200M
2020-10-28Series E· $100M
2019-11-12Series D· $55M
Leadership Team
Will Ahmed
Founder & CEO
Aurelian Nicolae
Co-Founder & Chief Hardware Engineer
Recent News
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Company data provided by crunchbase