Senior Advisor, Regulatory and Clinical Affairs

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 forguidingregulatoryandclinicalstrategies toensure an optimized, successful, timelyand resourceful commercialization of CZM's global product portfolio in the United States.The individualis responsible forregulatory strategy andsupport of a variety of FDA submissions including pre-submissions (Q-subs), pre-market notifications(510(k)s), pre-market approval applications (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 requirements(e.g.product design / design controls, clinical requirements, marketing material review et al.) Reviewproduct claims and plans for substantiation of those, and decides upon adequacy of claim substantiation Prepare andparticipatein meetings withUSFDA Concludeonadequacy ofpromotional and educational materials forappropriate regulatorycontentin case of unclear aspects. Support Product Complaint investigations, asrequired. Support BIMO audits, as needed Drivingresolutions of questions from FDA, pre- and post-market Do you qualify? Master's degree with emphasis inthe PhysicalSciences, Mathematics, Statistics, or Engineering with a strong clinical foundationrequired.Stronglyprefer 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 leastfifteen(15) yearsdemonstratedexperience with FDA, or working relationship with FDA(or 8+ years with M.D.).Directexperience workingat theAgencyisstrongly preferred. Must have excellent communication skills, both written and oral, and must be computer literate. A strong background in refractive surgery,IOL technology,visionscienceand statistical analysis is desirable. The annual pay range for this position is $183,000 - $228,800 The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent. This position is also eligible for a performance bonus We have amazing benefits to support you as an employee at ZEISS! Medical Vision Dental 401k Matching Employee Assistance Programs Paid time off including vacation, personal, and sick days The list goes on! ZEISS is an Equal Opportunity Employer Your ZEISS Recruiting Team: Jo Anne Mittelman 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). #J-18808-Ljbffr ZEISS Meditec Inc.