Carl Zeiss Pty Ltd is seeking a Regulatory Affairs Manager for their software division, focusing on medical technology, particularly in ophthalmology and neurosurgery. The role involves developing and implementing international regulatory strategies, collaborating with various teams, and ensuring compliance with evolving regulations
Job Summary
Definition and implementation of regulatory international approval strategies for complex, demanding development projects for innovative medical software solutions in ophthalmology and neurosurgery.
Continuous collaboration in project teams for new and further product developments from product definition to market launch.
Close collaboration with internal departments (R&D, project management, product management, marketing communications, clinical affairs, international RA contacts in respective markets) as well as with external authorities and partners.
Matching Summary
Match Score: 85
Carl Zeiss Pty Ltd is seeking a Regulatory Affairs Manager for their software division, focusing on medical technology, particularly in ophthalmology and neurosurgery. The role involves developing and implementing international regulatory strategies, collaborating with various teams, and ensuring compliance with evolving regulations.
Skills & Requirements
Must-have
regulatory international approval strategies
medical software solutions
product marketing material review
global submission dossiers
Nice-to-have
driving process optimization
international environment communication
Key Requirements
University degree in technical, economic, business, or comparable field
Extensive professional experience in Regulatory Affairs for medical software