ZEISS Group

Senior Advisor, Regulatory and Clinical Affairs

ZEISS Group

full-time

Posted on:

Location Type: Remote

Location: California • Connecticut • United States

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Salary

💰 $183,000 - $228,800 per year

Job Level

Senior

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical strategiesclinical studiesstatistical analysisregulatory submissions510kPMAIDEproduct designdesign controlsclinical requirements
Soft Skills
communication skillscoachingtrainingleadershipstrategic thinkingproblem-solvingcollaborationguidancepresentation skillsthought leadership
Certifications
Master’s degreeO.D.Ph.D.M.D.