Director, Regulatory Affairs and Quality Assurance

Overview

Our mission at Oura is to make health a daily practice, empowering every person to own their inner potential. Our award-winning products help our global community with daily insights to inspire healthy lifestyles. We've helped millions of people understand and improve their health.

At Oura we are building a complete platform for preventative health, from sleep optimization to metabolic health, women’s health, stress management and heart health tracking. We view Oura Ring as a clinical grade device in a consumer package rather than as a technology product.

For us, empowering the world starts with living our values and empowering our team. As a quickly growing company we work to ensure that our team members have what they need to do their best work — both in and out of the office.

We are looking for a Senior Director, Regulatory Affairs and Quality Assurance to play a key role in shaping Oura’s future products and services.

What you will do

• Lead regulatory and quality strategy for product development, approval, and lifecycle management for all regulated features.
• Ensure compliance with FDA, CE (MDR), and other relevant global regulatory frameworks.
• Review marketing and promotional materials for regulated and general wellness features.
• Serve as the primary liaison with regulatory agencies and notified bodies.
• Guide the creation and submission of regulatory filings including 510(k)s, De Novo submissions, and international registrations.
• Partner with science, data science, engineering, clinical, marketing, and legal teams to integrate regulatory requirements into product design and development, including clinical evidence strategy.
• Oversee post-market surveillance, adverse event reporting, and regulatory audits.
• Build and manage the RA / QA team, including hiring, mentoring, and performance development.
• Monitor regulatory changes and trends, advising the executive team on potential business impacts.
• Ensure an effective Quality Management System (QMS).

This is a remote US role.

Requirements

Benefits

Oura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates’ pay will be determined based on job-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future.

Compensation ranges by region

We are not considering candidates residing in the following states : Alaska (AK), Arkansas (AR), Delaware (DE), Iowa (IA), Mississippi (MS), Missouri (MO), Nebraska (NE), Rhode Island (RI), South Dakota (SD), Vermont (VT), West Virginia (WV), and Wisconsin (WI).

Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics.

We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Disclaimer : Beware of fake job offers!

We’ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note :

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To all recruitment agencies : Oura does not accept agency resumes. Please do not forward resumes to our jobs alias, Oura employees, or any other organization's location. Oura is not responsible for any fees related to unsolicited resumes.

Job details

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