Senior SaMD Regulatory Specialist

Ouraring; Northern (KY); Hybrid; USD 128,000 - 178,000; Full time

Benefits offered by this job

Competitive salary and equity packages

Health, dental, vision insurance

Oura Ring for you + employee discounts

Paid time off and holidays

Job summary

Oura seeks a Senior Regulatory Affairs Specialist to drive regulatory strategy and operations for our SaMD portfolio. You will work across quality, engineering, product, clinical, and legal teams to ensure compliant, efficient regulatory activities throughout the product lifecycle.

The role requires hands-on experience with medical devices or digital health, strong project coordination, and excellent communication.

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 EU MDR, ISO 13485, IEC 62304, ISO 14971.
• Experience compiling and maintaining regulatory documentation in a controlled environment.

Responsibilities

• 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, change assessment logs
• Support design change assessments and 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
• Contribute to inspection and audit readiness by organizing regulatory evidence and ensuring documentation is current
• Monitor evolving regulations, guidance, and standards relevant to SaMD and translate changes into actions
• Collaborate with cross-functional stakeholders to improve regulatory processes, templates, and tools for scale and efficiency

Skills

Regulatory strategy

Cross-functional collaboration

Project coordination

Documentation management

Attention to detail

Communication skills

Education

Bachelor’s degree in a scientific, engineering, healthcare, or related discipline

Tools

Regulatory submissions tools

Document control systems

eQMS familiarity

Job description

Oura seeks a Senior Regulatory Affairs Specialist to drive regulatory strategy and operations for our SaMD portfolio. You will work across quality, engineering, product, clinical, and legal teams to ensure compliant, efficient regulatory activities throughout the product lifecycle.

The role requires hands-on experience with medical devices or digital health, strong project coordination, and excellent communication.