Head of Regulatory Affairs Americas
LedgerSalary not specified
- Full Time
- Junior (1 to 2 years)
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Health Technology, Wearable Technology, Medical DevicesIndustries
Director, Regulatory Affairs and Quality Assurance
Salary: $206,000
Location Type: Remote (US)
Employment Type: [Not Specified]
Position 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 the 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.
Responsibilities
- 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
We would love to have you on our team if you have:
- Bachelor’s degree in life sciences, engineering, regulatory affairs, or a related field; advanced degree preferred.
- 8+ years of regulatory affairs experience in medical devices, digital health, or wearable technology, with experience in consumer-facing wearables strongly preferred.
- Proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals.
- Proven track record of successful management of a quality system, including external audits.
- Deep understanding of software as a medical device (SaMD) and cybersecurity regulations.
- Experience with privacy and data regulations (e.g., HIPAA, GDPR).
- Excellent leadership, communication, and stakeholder management skills.
- Ability to thrive in a fast-paced, dynamic startup environment.
Benefits
At Oura, we care about you and your well-being. What we offer:
- Competitive salary and equity packages
- Health, dental, vision insurance, and mental health resources
- An Oura Ring of your own plus employee discounts for friends & family
- 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off
- Paid sick leave and parental leave
Note on Pay: 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.
- Region 1: $206,000 - $257,000
- Region 2: $190,000 - $237,000
- Region 3: $178,000 - $223,000
A recruiter can determine your zones/tiers based on your US location.
Application Instructions
[Not Specified]
Company Information
Oura is dedicated to making health a daily practice and empowering individuals to understand and improve their health through innovative, award-winning products. We are building a comprehensive platform for preventative health, with a focus on sleep, metabolic health, women's health, stress management, and heart health tracking.
We are not considering candidates residing in the following states: Alaska (AK), Arkansas (AR).
Skills
Regulatory Affairs
Quality Assurance
FDA compliance
CE MDR
510(k) submissions
De Novo submissions
Product Development
Lifecycle Management
Marketing Review
Regulatory Filings
Clinical Evidence Strategy
Post-Market Surveillance
Adverse Event Reporting
Regulatory Audits
Team Management
Leadership
Oura
Wearable health monitoring smart ring
About Oura
Oura offers a smart ring that tracks various health metrics, including sleep patterns, heart rate variability, and physical activity. The ring uses advanced sensors to collect data, which is then analyzed and displayed through a mobile app, providing users with insights to improve their health and lifestyle. Unlike many competitors, Oura focuses on a direct-to-consumer model, selling its rings through its website and collaborating with sports teams and health institutions for additional partnerships. The goal of Oura is to help users, including athletes and those with health conditions, optimize their health through data-driven insights.
Oulu, FinlandHeadquarters
2013Year Founded
$344.1MTotal Funding
SERIES_DCompany Stage
Biotechnology, HealthcareIndustries
501-1,000Employees