Senior Regulatory Affairs Specialist

Ōura · Other

Jelentkezés →
Full Time$127,500 - $178,000Közzétéve: 2026. aug. 27.

Forrás: Oura

RÖVIDEN
Honnan végezhető
Nem elérhető
Kategória
Other
Fizetés
$127,500 - $178,000
Foglalkoztatás
Full Time
Tapasztalat
Senior
Közzétéve
2026. aug. 27.

This role’s source listing does not include Hungary as an eligible location.

Ōura is seeking a Senior Regulatory Affairs Specialist to manage regulatory operations for Software as a Medical Device products, with the role being fully remote within the United States.

The specialist will drive regulatory strategy and documentation for the company's SaMD portfolio, ensuring compliance across product lifecycles. Key responsibilities include supporting submissions, managing registrations, performing change assessments, and maintaining audit readiness in collaboration with cross-functional teams.

Miért fogod szeretni ezt a pozíciót

Location: United States
Salary: $127,500 - $178,000
Seniority: Senior
Focus: SaMD Regulatory Affairs
Benefits: Equity packages included.

Amit hozol magaddal

Bachelor’s degree in a scientific, engineering, or healthcare discipline
5+ Years of experience in regulatory affairs or operations within medical devices or digital health
Experience supporting software-based medical products or SaMD
Familiarity with FDA medical device requirements, EU MDR, ISO 13485, IEC 62304, and ISO 14971
Experience compiling and maintaining regulatory documentation in a controlled environment
Strong project coordination, organization, and document management skills.

Erre számíthatsz

Competitive salary and equity packages
Health, dental, vision insurance and mental health resources
Oura Ring and employee discounts
20 Days of paid time off plus 13 paid holidays and 8 days of flexible wellness time off
Paid sick leave and parental leave.

A cégről

Ōura is a health-technology company that produces the Oura Ring, a wearable device focused on sleep and activity tracking. They aim to empower individuals to improve their health through data-driven daily insights.

Ellenőrzött távmunkás állás · Közzétéve: 2026. aug. 27. · OuraJelentkezés →
Jelentkezés →