Senior SaMD Regulatory Lead - Submissions & Strategy

Ōura; United States; Remote; USD 140,000 - 190,000; Full time

Benefits offered by this job

Competitive salary

Health, dental, vision insurance

Employee discounts

Paid time off and holidays

Sick leave and parental leave

Job summary

Oura seeks a Senior Regulatory Affairs Specialist to drive regulatory strategy and operations for its SaMD portfolio. You will support submissions, maintain regulatory docs, and coordinate changes across product lifecycle while collaborating with quality, engineering, product, clinical, and legal teams in a fast-paced setting.

The role requires hands-on regulatory experience in medical devices or digital health, strong organizational skills, and excellent communication abilities to ensure

Qualifications

• 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 regulatory frameworks and standards: FDA medical device requirements, EU MDR, ISO 13485, IEC 62304, 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 attention to detail.

Responsibilities

• Lead regulatory and quality strategy for product development and lifecycle.
• Support regulatory operations lead for SaMD across development, submission, launch, and post-market.
• Coordinate preparation, publishing, and archival of regulatory submissions and related correspondence.
• Maintain regulatory documentation: submission trackers, listings, commitments, approvals, change logs.
• Support design change assessments and determine regulatory filing impact for software updates.
• Track submission milestones, approvals, renewals, and post-market reporting.
• Support UDI, registration, listing, and market access maintenance where applicable.
• Contribute to inspection and audit readiness by organizing evidence.
• Monitor evolving regulations and translate changes into operational actions.
• Collaborate with cross-functional stakeholders to improve processes, templates, and tools.

Skills

Regulatory affairs

Documentation management

Cross-functional

Regulatory strategy

Project coordination

Communication

Education

Bachelor’s degree in science/engineering/healthcare

Tools

eQMS

Regulatory submission tools

Job description

Oura seeks a Senior Regulatory Affairs Specialist to drive regulatory strategy and operations for its SaMD portfolio. You will support submissions, maintain regulatory docs, and coordinate changes across product lifecycle while collaborating with quality, engineering, product, clinical, and legal teams in a fast-paced setting.

The role requires hands-on regulatory experience in medical devices or digital health, strong organizational skills, and excellent communication abilities to ensure