Senior Advisor, Regulatory And Clinical Affairs

Carl Zeiss Pty Ltd

Remote, US
Base: $183,000 – $228,800; bonus/equity: performan...
Fully remote
Fda submissions (510(k)s, pmas, ides)
Clinical research design and execution
Us fda regulatory perspective
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

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.
  • ZEISS offers a comprehensive benefits package including medical, vision, dental, 401k matching, employee assistance programs, and paid time off.

Matching 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.

Salary

Base: $183,000 – $228,800; Bonus/Equity: performance bonus; Benefits: Medical, Vision, Dental, 401k Matching, EAP, PTO

Skills & Requirements

Must-have

  • FDA submissions (510(k)s, PMAs, IDEs)
  • Clinical research design and execution
  • US FDA regulatory perspective
  • Ophthalmic device standards development
  • Promotional material review

Nice-to-have

  • Thought leader in Ophthalmology
  • Strong communication skills
  • Collaboration with global teams

Key Requirements

  • Master's degree in Physical Sciences, Mathematics, Statistics, or Engineering
  • 15 years FDA-regulated environment experience
  • 15 years FDA working relationship experience
  • O.D., Ph.D. or M.D. strongly preferred
  • Refractive surgery, IOL technology, vision science background desirable

Work Rights

Not specified

Tailored Resume

Cover Letter