Senior Advisor, Regulatory and Clinical Affairs
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Job Description
Senior Advisor for Regulatory and Clinical Affairs focused on optimizing FDA submissions. Collaborate on clinical strategies for CZM's medical device portfolio in the US.
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
Requirements:
- 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 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.).
- 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, vision science and statistical analysis is desirable.
Benefits:
- Medical
- Vision
- Dental
- 401k Matching
- Employee Assistance Programs
- Paid time off including vacation, personal, and sick days
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