Senior Specialist, Regulatory Affairs (Americas & ANZ)
Core
Develop and execute regulatory strategies for new and existing business channels in ANZ and the Americas, managing premarket registrations and post-market compliance for medical devices and software.
Role type
Senior Regulatory Affairs Specialist (Americas & ANZ)
Builds
Premarket registration submissions, regulatory compliance strategies, and regional entity licensing for health products.
Domain
Medical devices, digital health technologies, and connected healthcare products
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, premarket registration management, post-market surveillance, technical writing, stakeholder influence, risk management principles, ISO 13485/14971 knowledge
Preferred skills
Entity licensing experience, RAC certification, experience with software-based medical devices, matrixed global organization experience
Technologies
None explicitly listed beyond regulatory frameworks
Responsibilities
Develop regional regulatory strategies for ANZ and Americas; manage premarket registration submissions and continuance of compliance; maintain regulatory records and track approvals; support regional entity creations; communicate with internal/external customers and health agencies; monitor external standards and share significant regulatory changes globally.
Seniority
Senior, hands-on IC with mentorship responsibilities
