Quality Assurance Auditor performing quality assurance audits for Pharmacy Benefit Dimensions. Ensuring compliance with regulatory requirements and collaborating with teams for effective audit processes.
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.
Requirements
- 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.
Benefits
- Competitive base salaries
- Meaningful equity
- Consistent pay practices
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