Note: The job is a remote job and is open to candidates in USA. ZEISS Group is a pioneer in science with over 179 years of experience in various sectors including Medical Technology. The Senior Advisor, Regulatory and Clinical Affairs, is responsible for guiding regulatory and clinical strategies to ensure successful commercialization of products in the US, providing expertise in FDA submissions and clinical research design.
Responsibilities
- Provide input to regulatory and clinical strategies of all CZM products for the US market to ensure adequate and most efficient 510ks, 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 et al.)
- 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
Skills
- Master's degree with emphasis in the Physical Sciences, Mathematics, Statistics, or Engineering with a strong clinical foundation required
- Thought leader in the Ophthalmology and/or vision science fields and recognized for their 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.)
- Must have excellent communication skills, both written and oral, and must be computer literate
- O.D., Ph.D. or M.D
- Direct experience working at the Agency is strongly preferred
- A strong background in refractive surgery, IOL technology, vision science and statistical analysis is desirable
Benefits
- Performance bonus
- Medical
- Vision
- Dental
- 401k Matching
- Employee Assistance Programs
- Paid time off including vacation, personal, and sick days
Company Overview
Company H1B Sponsorship