Senior Advisor, Regulatory and Clinical Affairs

Overview

About Us: ZEISS has been in business for over 179 years. ZEISS is a global company with a diverse range of portfolios across Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 46,000 employees and have over 4,000 in the US and Canada. Make a difference, come join the team!

Location/Region: This position is a remote role.

What s the role?

The Senior Advisor, Regulatory and Clinical Affairs, US 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. The individual is responsible for regulatory strategy and support of a variety of FDA submissions including pre-submissions (Q-subs), pre-market notifications (510(k) s), pre-market approvals (PMAs) and investigational device exemptions (IDEs).

In addition, they are responsible for advice and support to guide the necessary clinical research that enables the business to deliver market-changing innovations in medical devices. They have significant oversight and contribution to the design of clinical research studies in the US. They are an expert resource during the execution of these studies. They collaborate with CZM product development centers and US SSC Regulatory and Clinical teams to create strategic plans to support US (and potentially global) market approvals.

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; for all functions (e.g. RA, CA, RnD, Marketing/Product Management, Mar Com), and for all CZM product development centers globally.

The Senior Advisor Regulatory and Clinical Affairs utilizes their expertise to participate in the standards development process for ophthalmic device related standards convened by the Vision Council in support of the American National Standards Institute (ANSI).

The individual may contribute to the development of SOPs which require RA and/or CA input to reflect US requirements.

The incumbent acts as a liaison to US FDA and represents CZM at meetings with the agency as well as with external standards organizations.

• Provide input to regulatory and clinical strategies of all CZM products for the US market to ensure adequate and most efficient 510(k) s, PMAs, and IDEs
• Participate in strategy and management meetings, as needed to provide guidance and Agency perspective
• Demonstrated expertise in the design and implementation of complex clinical strategies to support global regulatory and market needs
• Expertise in the design and execution of clinical studies which optimize the use of clinical data for global product approvals
• Coach / train CZM organizations on US requirements (e.g. product design / design controls, clinical requirements, marketing material review, etc.)
• Review product claims and plans for substantiation of those, and decides upon adequacy of claim substantiation
• Prepare and participate in meetings with US FDA
• Conclude on adequacy of promotional and educational materials for appropriate regulatory content in case of unclear aspects
• Support Product Complaint investigations, as required
• Support BIMO audits, as needed
• Driving resolutions of questions from FDA, pre- and post-market

• Master s degree with emphasis in the Physical Sciences, Mathematics, Statistics, or Engineering with a strong clinical foundation required. Strongly prefer O.D., Ph.D. or M.D.
• Thought leader in the Ophthalmology and/or vision science fields and recognized for contributions and/or publications in the field.
• Fifteen (15) years of experience in an FDA-regulated environment (or 8+ years with M.D.).
• At least fifteen (15) years demonstrated experience with FDA, or working relationship with FDA (or 8+ years with M.D.). Direct experience working at the Agency is strongly preferred.
• Must have excellent communication skills, both written and oral, and must be computer literate.
• A strong background in refractive surgery, IOL technology,…