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$183k

Per Year

Position range in Kansas City, MO-KS Metropolitan Statistical Area $67k

•$118k Per Year Senior Advisor, Regulatory and Clinical Affairs .

Medical Technology

Occupation:

Business Operations Specialists, All Other

Location:

Kansas City, MO

•64118

Job Type:

Full Time (30 Hours or More)

Posted:

05/07/2026

Positions available: 1

Source:

FileImport

•Medical Technology

Web Site:

www.zeiss.com

Expires:

09/28/2026

Job #:

JR1046835MO

Job Requirements and Properties

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Full Time Schedule

Full Time

Job Description

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About Us:

How many companies can say they've been in business for over 179 years?!

Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles ever-changing environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 46,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!

Location/Region:

This position is a remote role.

What's the role?

The Senior Advisor,Regulatory and Clinical Affairs,USis responsible forguidingregulatory and clinical strategies to ensure an optimized, successful,timelyand resourceful commercialization of CZM's global product portfolio in the United States.

The individualis responsible forregulatory strategy andsupportofa variety of FDA submissionsincluding pre-submissions (Q-subs), pre-market notifications(510(k)s), pre-market approvalapplications (PMAs)andinvestigational device exemptions (IDEs). Inaddition, theyare responsible foradvice andsupporttoguidethe necessaryclinical research that enables the business to deliver market-changing innovations in medical devices. Theyhave significant oversightandcontributiontothe designof clinical research studiesin the US.They arean expert resourceduring the execution of these studies.

Theycollaboratewith CZMproduct development centers and US SSC Regulatory and Clinical teamsto create strategic plansto supportUS (and potentiallyglobal)market approvals. This roleacts as an advisorand subject matter expertfor US regulatoryand clinicalquestions, specifically interpreting US FDA's perspective,at all levels, from senior management to single contributors;for all functions (e.g. RA, CA,RnD, Marketing/Product Management, MarCom), and for all CZMproduct development centersglobally. The Senior Advisor Regulatory and Clinical Affairsutilizestheirexpertisetoparticipateinthestandardsdevelopmentprocess forophthalmic device related standardsconvenedby theVision Council in support of the American National Standards Institute (ANSI). The individual maycontributetothedevelopment ofSOPs which requireRAand/or CA input to reflect US requirements. The incumbentacts as aliaison to USFDA andrepresents CZM at meetings with the agencyas well as with externalstandardsorganizations.

Sound Interesting? Here's what you'll do:

Provide input to regulatory and clinical strategies of all CZM products for the US marketto ensure adequate and most efficient510ks, PMAs, and IDEs Participate in strategy and management meetings, as neededto provide guidance andAgencyperspective Demonstratedexpertiseinthe design and implementation ofcomplex clinical strategies to support global regulatory and market needs. Expertisein the design and execution of clinical studies whichoptimizethe use of clinical data for global product approvals Coach / train CZM organizations on US ...For full information see follow application link.

We are an EEO/AA/Veterans/Disabled employer. Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen 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).