Senior Regulatory Affairs Specialist
Core
Develop and execute regulatory strategies for innovative medical devices, software, and AI-enabled technologies to bring them to market across the US, Europe, and Australia.
Role type
Senior Regulatory Affairs Specialist
Builds
Medical devices, software, and AI-enabled technologies for orthopedic and digital health markets
Domain
Medical devices, Orthopedics, Digital Health, AI/ML
Deliverable
production ML models | product features
Required skills
Regulatory strategy development, FDA 510(k) submissions, EU MDR technical documentation, TGA submissions, Risk management (ISO 14971), Quality management (ISO 13485), Pre-submission meeting management, Post-market surveillance, AI/ML regulatory knowledge
Preferred skills
Software/SaMD experience, AI/ML experience, TGA experience
Technologies
FDA 510(k), EU MDR, TGA, ISO 13485, ISO 14971
Responsibilities
Lead regulatory submissions (FDA 510(k), EU MDR, TGA), Provide regulatory guidance on product development and risk management, Interact with regulatory authorities (FDA, Notified Bodies, TGA), Support post-market activities and audits, Monitor regulatory changes and advise the business
Seniority
Senior, hands-on IC
