Senior Regulatory Affairs Specialist

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🔥 0 minutes ago

🐻 Alaska, Iowa, +6 more states – Remote

🐻 Alaska – Remote 🌾 Iowa – Remote 🌾 Nebraska – Remote 🎸 Mississippi – Remote 🗿 South Dakota – Remote ⚔️ Virginia – Remote ⛰️ West Virginia – Remote 🧀 Wisconsin – Remote

💵 $127.5k - $178k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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ŌURA

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

🏭 Manufacturing

💼 Consulting

Healthcare • Manufacturing • Consulting

ŌURA is a company that produces smart rings designed to provide in-depth health metrics and insights. The Oura Ring tracks a variety of health-related data such as sleep patterns, heart rate, activity levels, and stress. It aims to help users live healthier and more productive lives through accurate biometrics tracked via a comfortable ring worn all day and night. With features that benefit women's health, heart health, and overall wellness, ŌURA rings are marketed as both technologically advanced and user-friendly devices for personal health monitoring.

📋 Description

• Lead regulatory and quality strategy for product development, approval, and lifecycle management for wellness and regulated features • Support regulatory operations lead for SaMD products across development, submission, launch, and post-market phases • Coordinate preparation, compilation, publishing, and archival of regulatory submissions and related correspondence • Maintain regulatory documentation, including submission trackers, product registrations/listings, regulatory commitments, approvals and clearance records, and change assessment logs • Support design change assessments and help determine regulatory filing impact for software updates, labeling changes, and product modifications • Track and communicate submission milestones, approvals, renewals, and post-market reporting requirements • Support UDI, registration, listing, and market access maintenance activities where applicable • Contribute to inspection and audit readiness by organizing regulatory evidence and ensuring documentation is current and inspection-ready • Monitor evolving regulations, guidance, and standards relevant to SaMD, and help translate changes into operational actions • Collaborate with cross-functional stakeholders to improve regulatory processes, templates, and tools for scale and efficiency

🎯 Requirements

• Bachelor’s degree in a scientific, engineering, healthcare, or related discipline • 5+ years of experience in regulatory affairs or regulatory operations within medical devices, digital health, or other regulated healthcare products • 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 • Excellent written and verbal communication skills • Ability to manage multiple priorities and deadlines with strong attention to detail • Experience supporting 510(k), De Novo, technical documentation, or international registrations • Familiarity with eQMS, document control, and submission management tools • Experience with software change assessments, traceability, and lifecycle documentation • Understanding of cybersecurity, labeling, and post-market requirements for SaMD • RAC certification or other relevant regulatory training is a plus • Experience working in a fast-paced startup or high-growth medtech environment is preferred

🏖️ Benefits

• 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