Senior Advisor, Regulatory and Clinical Affairs - Remote

Overview

The Senior Advisor, Regulatory and Clinical Affairs at ZEISS is responsible for guiding regulatory and clinical strategies to ensure successful commercialization of products in the US market.

In Short

• Remote position at ZEISS, a global company with over 179 years of history.
• Responsible for regulatory strategy and FDA submissions including 510(k)s and PMAs.
• Guides clinical research necessary for market-changing innovations in medical devices.
• Collaborates with product development and regulatory teams to create strategic plans.
• Acts as a subject matter expert on US regulatory and clinical questions.
• Participates in standards development for ophthalmic devices.
• Coaches CZM organizations on US regulatory requirements.
• Prepares for meetings with the US FDA and external standards organizations.
• Requires a Master’s degree with emphasis in Physical Sciences or Engineering.
• Offers an annual salary range of $183,000 – $228,800.

Requirements

• Master’s degree in relevant fields; O.D., Ph.D. or M.D. preferred.
• 15 years of experience in an FDA-regulated environment.
• Strong communication skills and computer literacy.
• Desirable background in refractive surgery and vision science.
• Direct experience with FDA is preferred.

Benefits

• Medical, Vision, Dental insurance.
• 401k Matching.
• Employee Assistance Programs.
• Paid time off including vacation and sick days.
• Performance bonus eligibility.