Senior Advisor, Regulatory And Clinical Affairs

Carl Zeiss Pty Ltd

Remote
$183,000 – $228,800 py
Remote
Us regulatory and clinical strategy
Fda submissions (510k, pma, ide)
Clinical research design and execution
Carl Zeiss Pty Ltd is seeking a Senior Advisor for Regulatory and Clinical Affairs, responsible for guiding regulatory strategies and clinical research for their product portfolio in the US. The ideal candidate should have extensive experience with FDA regulations and a strong background in ophthalmology or vision science. This remote role offers a competitive salary and comprehensive benefits

Job Summary

  • The Senior Advisor, Regulatory and Clinical Affairs is responsible for guiding regulatory and clinical strategies to ensure an optimized, successful, timely and resourceful commercialization of CZM’s global product portfolio in the United States.
  • This role acts as an advisor and subject matter expert for US regulatory and clinical questions, specifically interpreting US FDA’s perspective, at all levels, from senior management to single contributors.
  • The annual pay range for this position is $183,000 – $228,800, and this position is also eligible for a performance bonus.

Matching Summary

Match Score: 85

Carl Zeiss Pty Ltd is seeking a Senior Advisor for Regulatory and Clinical Affairs, responsible for guiding regulatory strategies and clinical research for their product portfolio in the US. The ideal candidate should have extensive experience with FDA regulations and a strong background in ophthalmology or vision science. This remote role offers a competitive salary and comprehensive benefits.

Salary

$183,000 – $228,800

Skills & Requirements

Must-have

  • US regulatory and clinical strategy
  • FDA submissions (510k, PMA, IDE)
  • Clinical research design and execution
  • Ophthalmology device standards
  • Liaison with US FDA

Nice-to-have

  • Thought leader in ophthalmology
  • Refractive surgery expertise
  • IOL technology knowledge
  • Vision science background
  • Statistical analysis skills

Key Requirements

  • Master's degree in Physical Sciences, Mathematics, Statistics, or Engineering with clinical foundation
  • 15 years of experience in FDA-regulated environment (or 8+ years with M.D.)
  • 15 years demonstrated experience with FDA (or 8+ years with M.D.)
  • Excellent communication skills, both written and oral
  • Computer literate

Work Rights

Not specified

Tailored Resume

Cover Letter