Regulatory Affairs Manager Software (m/w/x)

Carl Zeiss Pty Ltd

Multiple Locations
Regulatory affairs software
Medical device software
International regulatory strategy
Define and implement international regulatory approval strategies for complex, innovative medical software solutions in ophthalmology and neurosurgery

Job Summary

  • Define and implement international regulatory approval strategies for complex, innovative medical software solutions in ophthalmology and neurosurgery.
  • Drive the implementation for digital medical products in markets with diverging registration requirements and create independent submission dossiers for global markets.
  • Optimize global, cross-site Regulatory Affairs processes and collaborate closely with internal departments and external authorities.

Matching Summary

Define and implement international regulatory approval strategies for complex, innovative medical software solutions in ophthalmology and neurosurgery.

Skills & Requirements

Must-have

  • Regulatory Affairs Software
  • Medical Device Software
  • International Regulatory Strategy
  • Product Launch
  • Global Markets

Nice-to-have

  • Analytical skills
  • Creative problem-solving
  • International communication
  • Organizational talent

Key Requirements

  • Higher education degree
  • Extensive experience in Regulatory Affairs for medical software
  • Project management experience
  • Excellent English and German language skills

Work Rights

Not specified

Tailored Resume

Cover Letter