Senior Advisor, Regulatory and Clinical Affairs

About Us:

ZEISS is a global company with more than 179 years of history, serving diverse industries including industrial quality & research, medical technology, consumer markets, and semiconductor manufacturing technology. We have over 46,000 employees worldwide, with more than 4,000 in the US and Canada.

Location/Region:
This position is a remote role.

Senior Advisor, Regulatory and Clinical Affairs, US. This role is responsible for guiding regulatory and clinical strategies to ensure a successful, timely, and resourceful commercialization of CZM’s global product portfolio in the United States.

• Provide input to regulatory and clinical strategies for all CZM products for the US market.
• Participate in strategy and management meetings to provide guidance and agency perspective.
• Design and implement complex clinical strategies to support global regulatory and market needs.
• Design and execute clinical studies that optimize the use of clinical data for global product approvals.
• Coach & train CZM organizations on US requirements such as product design controls, clinical requirements, and marketing material review.
• Review product claims and plans for substantiation and decide upon adequacy of claim substantiation.
• Prepare and participate in meetings with US FDA.
• Determine the adequacy of promotional and educational materials for regulatory compliance.
• Support product complaint investigations as required.
• Support BIMO audits as needed.
• Drive resolution 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. Preference for O.D., Ph.D., or M.D.
• Thought leader in ophthalmology and/or vision science fields with recognized contributions and publications.
• Fifteen (15) years of experience in an FDA-regulated environment (or 8+ years with M.D.).
• At least fifteen (15) years of demonstrated experience with FDA or working relationship with FDA (or 8+ years with M.D.); direct experience at the Agency strongly preferred.
• Excellent written and oral communication skills and computer literacy.
• Strong background in refractive surgery, IOL technology, vision science, and statistical analysis desirable.

Annual pay range: $183,000 – $228,800. The position is also eligible for a performance bonus.

• Medical
• Vision
• Dental
• 401(k) Matching
• Employee Assistance Programs
• Paid time off, including vacation, personal, and sick days
• Other benefits continue to be provided.

Zeiss provides Equal Employment Opportunity without unlawful regard to an applicant’s race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizenship status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).

Contact:
Jo Anne Mittelman, Recruiting Team