ZEISS Group · 11 hours ago
Senior Advisor, Regulatory and Clinical Affairs
United States
Full-time
Remote
Senior Level, Lead/Staff
$183K/yr - $229K/yr
15+ years expZEISS Group is a pioneering company with over 179 years of experience in advancing technology and innovation. The Senior Advisor, Regulatory and Clinical Affairs, is responsible for guiding regulatory and clinical strategies to ensure successful commercialization of medical devices in the US, collaborating with various teams to support market approvals and clinical research initiatives.
HardwareManufacturingPhotography
Hiring Manager
Jo Anne Mittelman-CDSP
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
Qualification
Required
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
Preferred
Strongly prefer 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
Medical
Vision
Dental
401k Matching
Employee Assistance Programs
Paid time off including vacation, personal, and sick days
Company
ZEISS Group
Zeiss is a manufacturer of optical systems, industrial measurements, and medical devices.
10001+ employees
H1B Sponsorship
ZEISS Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2023 (1)
2021 (6)
Funding
Current Stage
Late StageLeadership Team
Jörg Marzel
Global CISO
Norbert Gergely
Head of Data Architecture and Lifecycle
Recent News
2025-12-18
2025-12-18
2025-12-11
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