Regulatory Affairs Manager Software (m/w/x)

Carl Zeiss Pty Ltd

Not specified
Regulatory affairs experience with medical software
International regulatory strategy (eu mdr, fda, nmpa)
Experience with ophthalmology or neurosurgery products
Carl Zeiss Pty Ltd is seeking a Regulatory Affairs Manager for their innovative medical software solutions in ophthalmology and neurosurgery. The ideal candidate will have significant experience in regulatory affairs within the medical technology sector, specifically related to software products, and must demonstrate strong analytical and communication skills

Job Summary

  • The role involves defining and implementing international regulatory approval strategies for complex medical software projects in ophthalmology and neurosurgery.
  • Candidates will collaborate closely with internal R&D, product management, and external authorities to drive global market registrations and compliance.
  • The position requires overseeing the entire product lifecycle from definition to market launch while ensuring adherence to evolving regulations like EU MDR and FDA standards.

Matching Summary

Match Score: 85

Carl Zeiss Pty Ltd is seeking a Regulatory Affairs Manager for their innovative medical software solutions in ophthalmology and neurosurgery. The ideal candidate will have significant experience in regulatory affairs within the medical technology sector, specifically related to software products, and must demonstrate strong analytical and communication skills.

Skills & Requirements

Must-have

  • Regulatory Affairs experience with medical software
  • International regulatory strategy (EU MDR, FDA, NMPA)
  • Experience with ophthalmology or neurosurgery products
  • Strong analytical and project management skills
  • Fluency in English and German languages

Nice-to-have

  • Knowledge of economic relationships
  • Additional language skills beyond English and German
  • Experience with digital medicine products
  • Creative problem-solving abilities
  • Cross-functional team collaboration

Key Requirements

  • University degree in technical, business, or related field
  • Proven experience in Regulatory Affairs for medical device software
  • Project management experience required
  • Excellent verbal and written English and German proficiency

Work Rights

Not specified

Tailored Resume

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