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

🏢 ОфисDirectorПолная занятость

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Наша компания

JOIN THE SLEEP FITNESS MOVEMENT 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.

О роли

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. HIGH STANDARDS. NO APOLOGIES.

Чем предстоит заниматься

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

Наши требования

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

Мы предлагаем

Every role at Eight Sleep includes competitive compensation and benefits. Final compensation will depend on experience, location, and level

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

Eight Sleep

San Francisco

ГрейдDirector

ЗанятостьПолная занятость

РегионСША

ФорматОфис

ИсточникСкрыто

Опубликовано15 июля

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