At WHOOP, we're on a mission to unlock human performance. WHOOP empowers its members to perform at a higher level through a deep understanding of their bodies and daily lives. WHOOP is looking for a Director of Regulatory and Quality Systems to lead the quality management system and regulatory programs in order to facilitate rapid SaMD development and commercialization.
As the Director of Regulatory and Quality Systems, you will be joining the Digital Health team at WHOOP responsible for setting the vision, guiding the development of technologies, and implementing the system that will allow WHOOP to develop SaMD in a rapid, agile manner. In an innovative and evolving space, you will need to bring strategic leadership, best practices in holistic product development and also creative problem-solving with an ability to adapt to a changing landscape. Additionally, you will act as the expert consultant within WHOOP for teammates to learn and follow the policies and guidance you set and implement.
RESPONSIBILITIES:Lead and manage all domestic and international quality and regulatory-related initiatives for the Digital Health teamRefine and implement the quality management system within WHOOPDevelop and lead change-management efforts across multi-disciplinary teamsSupport and contribute to the overall strategic vision of WHOOPOversee global regulatory strategy and filing processMentor teammates and evangelize quality management and regulatory strategy within WHOOPCreate and maintain a budget for the quality and regulatory organizationEffectively communicate and manage quality and regulatory initiatives, deliverables, and milestones throughout the organization.Collaborate across WHOOP departments, as well as manage external vendor relationships for project successStay current with changes in the global compliance and regulatory environment and provide guidance to the Digital Health and management teamsQUALIFICATIONS:6+ years of broad experience with quality systems, with at least 2 years as a senior leader with direct responsibility for a quality system of a Software as Medical Device product(s)Deep understanding of quality system requirements (Part 820 and ISO 13485) and of common standards for medical device development (ISO 14971, ISO 62304, IEC 62366)Understanding and appreciation for holistic product development with strong working knowledge of risk management, software, human factors/usability engineering, and cybersecurityDemonstrated experience in implementing and owning change-managementProven ability to create a culture of accountability and ownershipExperience working within an agile team or in a startup environment is desiredApproach work with a lead-by-doing attitudeThis role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.
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. 