Senior Regulatory Affairs Specialist
Core
Lead regulatory and quality strategy for product development, approval, and lifecycle management for wellness and regulated features in a Software as a Medical Device (SaMD) portfolio.
Role type
Senior Regulatory Affairs Specialist (SaMD)
Builds
Software as a Medical Device (SaMD) products (via careerplan.io/jobs/4363806009-senior-regulatory-affairs-specialist-at-oura)
Domain
Digital Health / Medical Devices
Deliverable
production ML models
Required skills
Regulatory strategy, submission support, document management, change assessments, registrations, regulatory intelligence, inspection/audit readiness, FDA medical device requirements, EU MDR, ISO 13485, IEC 62304, ISO 14971, UDI, market access maintenance
Preferred skills
510(k), De Novo, technical documentation, international registrations, eQMS, document control, submission management tools, software change assessments, traceability, lifecycle documentation, cybersecurity, labeling, post-market requirements
Technologies
eQMS, document control systems
Responsibilities
Lead regulatory and quality strategy for product development, approval, and lifecycle management; Support regulatory operations lead for SaMD products across development, submission, launch, and post-market phases; Coordinate preparation, compilation, publishing, and archival of regulatory submissions; Maintain regulatory documentation including submission trackers, product registrations, and change assessment logs; Support design change assessments and determine regulatory filing impact for software updates; Track and communicate submission milestones, approvals, renewals, and post-market reporting requirements; Contribute to inspection and audit readiness; Monitor evolving regulations and translate changes into operational actions; Collaborate with cross-functional stakeholders to improve regulatory processes.
Seniority
Senior, hands-on IC