At Harrison.ai, we're building diagnostic AI solutions to support clinicians, aiming to scale global healthcare capacity and create a fairer, healthier world
Job Summary
At Harrison.ai, we're building diagnostic AI solutions to support clinicians, aiming to scale global healthcare capacity and create a fairer, healthier world.
The Regulatory Affairs Specialist will provide regulatory expertise throughout the product lifecycle, solve complex compliance challenges for SaMD products, and collaborate with a multi-disciplinary team.
The company offers opportunities to innovate for global good, collaborate across continents, scale potential with L&D budgets, and enjoy flexibility for life with WFH options and flexible hours.
Matching Summary
At Harrison.ai, we're building diagnostic AI solutions to support clinicians, aiming to scale global healthcare capacity and create a fairer, healthier world.
Skills & Requirements
Must-have
Software-as-Medical-Device (SaMD) compliance
Technical File creation and maintenance
Regulatory submission management
Global regulatory requirements
Vigilance reporting
Nice-to-have
AI and machine learning expertise
Collaborative team environment
Innovation and agility
Key Requirements
Minimum 2 years' experience in Medical Device Regulatory Affairs
Sound understanding of global medical device registration processes
Experience with TGA and EU MDR
Degree in software, engineering, science or related discipline