Director of Regulatory Affairs and Quality Assurance - Remote

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

In Short

• 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).

Requirements

• Experience in regulatory affairs and quality assurance in a health technology context.
• Strong understanding of FDA and international regulatory requirements.
• Proven leadership experience in managing teams.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively across multiple teams.
• Strong analytical and problem-solving skills.
• Experience with clinical evidence strategy is a plus.
• Knowledge of Quality Management Systems.

Benefits

• Competitive salary and equity options.
• Flexible working hours and remote work.
• Health and wellness benefits.
• Opportunities for professional development.
• Collaborative and inclusive company culture.