Director of Regulatory Affairs and Quality Assurance (RA / QA)

1 мес. назад

USADirector

Lead regulatory affairs and quality assurance to build business opportunities leveraging medical sleep technology.

Условия

Every role at Eight Sleep includes competitive compensation and benefits. Final compensation will depend on experience, location, and level. Benefits may include:
Competitive salary and equity
Full access to health, vision, and dental insurance for you and your dependents
Supplemental life insurance
Flexible PTO
Paid parental leave
Team offsite and company events
Employee discount on Eight Sleep products
Opportunity to work with a world-class team building category-defining technology
Your own Pod - and other great benefits Every Eight Sleep employee receives the very product that defines our mission: a Pod of their own. If you join us you’ll get your own Pod .

Другое

At Eight Sleep, we're on a mission to fuel human potential through optimal sleep. As the world's first sleep fitness company, we're redefining what it means to be well-rested and building the most advanced hardware, software, and AI technology to make it possible. Our products power peak mental, physical, and emotional performance by transforming every night of sleep into a personalized, data-driven recovery experience.
Every role at Eight Sleep is a chance to create cutting-edge technology, collaborate with world-class talent, and help shape a future where sleep isn't passive, it's a powerful tool for living better. If you're tired of the ordinary and driven to build at the edge of what's possible, this is your moment.
We operate with intensity because our mission demands it. At Eight Sleep, we bring the same mindset as the world's top performers: focused, relentless, and always pushing to be in the top 1% of our craft. This isn't a 9-to-5. Our team is deeply committed, often putting in the extra effort, not because we're told to, but because we're invested in building something category-defining.
Sleep is inherently tied to health, and we have an immense opportunity to leverage our Pod platform to detect medical conditions and to provide therapy. We are looking for a Director of Regulatory Affairs and Quality Assurance to help build a business around this opportunity. This role will provide leadership for risk management and oversee the operation of the quality management system, as well as serve as the primary interface between our company and regulatory agencies. This role will interact closely with R&D, Clinical, and the executive team. Your work will improve the lives of numerous users and will enable our core mission of improving sleep and saving lives.
This role is based out of our offices in San Francisco.
Shape risk management practices for the organization
Provide regulatory input and guide the company through multiple submissions
Oversee compliance and documentation practices
Collaborate with R&D, Clinical, and Operations to accelerate approvals
Implement and manage comprehensive post-market monitoring workflows
8+ years of industry experience in quality functions for medical devices
Successful track record of FDA clearance (510(k), De Novo)
Exemplary at cross-functional program management
Experience establishing and monitoring compliance to relevant standards (e.g., ISO 13485, ISO 14971)
Bachelor’s degree or equivalent experience