Quality Systems & Regulatory Affairs Manager, Medical Devices

At WHOOP, we're on a mission to unlock human performance. WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives.
WHOOP is seeking a Quality Systems & Regulatory Affairs Manager (Medical Devices) to navigate and manage regulatory and quality system processes for Medical Device Software. In this role, you will work with the WHOOP Medical Device Team to act as a champion of Quality Systems and Regulatory activities throughout the medical device lifecycle.
As a Quality Systems & Regulatory Affairs Manager, you will be responsible for various regulatory & quality functions, such as leading regulatory submissions, implementation of quality system post-market processes, collaborating with the WHOOP Medical Device Team throughout the product development process, and ensuring compliance with the Quality Management System (QMS). You will hold yourself and the team accountable for developing best-in-class, safe, and effective medical devices that address customer and regulatory requirements. Additionally, you will need to bring best practices and creative problem-solving abilities to support high-speed medical development in a consumer wearable company.
This role reports to the Director of Quality and Regulatory Affairs.

RESPONSIBILITIES:

• Develop and implement regulatory strategies and plans for the successful global registration and market clearance of the SaMD products
• Stay updated with evolving regulatory requirements, guidelines, and standards in multiple countries to ensure product compliance
• Lead the preparation and submission of regulatory documentation, such as pre-market applications, post-market reporting, and product change notifications
• Monitor and analyze changes in global regulatory landscapes related to SaMD products, providing strategic guidance to the organization on potential impacts
• Implement, monitor, and promote best practices of Quality Management Systems to ensure compliance with relevant FDA, EU, and global regulations/directives/requirements
• Conduct internal audits, risk assessments, and process evaluations to identify areas for improvement and ensure adherence to QMS procedures
• Coordinate external audits from regulatory authorities and notified bodies to facilitate product certifications and approvals
• Implement and oversee post-market surveillance activities, including adverse event reporting, complaint handling, and vigilance reporting in compliance with relevant regulations
• Provide medical device software development expertise for SaMD projects in the areas of Regulatory Compliance, Design Control, Clinical Studies,  Usability Engineering, and Risk Management as needed
• Foster organizational compliance with the quality system and regulatory requirements, including ongoing training and education on QMS and the regulatory landscape

QUALIFICATIONS:

• Bachelor’s Degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or related field, or equivalent practical experience
• 5+ years of experience in regulatory affairs and quality management systems for  medical device software
• Comprehensive knowledge of global regulatory requirements for SaMD products, including FDA, EU MDR, and other international regulations
• Strong understanding of ISO 13485 and other quality management system standards
• Proven experience in successful product registrations and market clearances in multiple countries
• Strategic thinking and problem-solving skills, with the ability to navigate complex regulatory challenges
• Leads by doing and demonstrates leadership and teamwork in a collaborative cross-functional environment
• Excellent organizational, interpersonal, verbal, and written communication skills
• Passion for delivering impactful and high-quality products to people
• Nice to Have: Experience with Consumer Wearable Products, General Wellness Products, Digital Health, Mobile Medical Applications, or Medical Device Data Systems (MDDS)
• Nice to Have: Experience with Machine Learning medical device technologies in an ambiguous, fast-paced, and innovative environment

Interested in the role, but don’t meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.
WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility