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Regulatory Affairs Specialist

Santa Ana, CA

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Johnson & Johnson Surgical Vision (JJSV) isrecruiting for a Regulatory Affairs Specialist in Santa Ana, CA. JJSV designs,nmanufactures, and distributes medical devices for the surgical treatment ofnanterior segment ophthalmic disorders, most notably cataract removal. Caring for the world, one person at a time has inspired andnunited the people of Johnson & Johnson for over 125 years. We embracenresearch and science -- bringing innovative ideas, products and services tonadvance the health and well-being of people. Employees of the Johnson &nJohnson Family of Companies work with partners in health care to touch thenlives of over a billion people every day, throughout the world. The Johnson & Johnson Surgical Vision goal isnimproving sight throughout a patientu2019s lifetime. J&J Surgical Visionnis well positioned to address a full range of vision health needs for globalnmarkets: The No. 2 global provider of CATARACT products and a leader innpresbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, allnsupported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops. Johnsonn& Johnson Surgical Vision has operations in the United States, LatinnAmerica, Asia-Pacific and Europe/Middle East/Africa regions. Research,ninnovation and new-product development are the focus of our organization. Ournassociates around the world are committed to expanding our brands andnfortifying our position as the worldwide leader in the industry. The primary responsibility of this individual is to providensupport to our international regulatory associates. You, Regulatory AffairsnSpecialist, will act as liaison between our regulatory teams and our R&D,nquality, and manufacturing sites, ensuring that all supportive documentation isncrafted and delivered in support of our foreign registrations. The Specialist, under limited supervision, will also benresponsible for capturing critical metrics and performance indices, andnreporting this information to senior management. Other responsibilities include,nbut are not limited to: Provide regulatory support to project teams,ncreates detailed Regulatory Plans/strategies and in-depth team involvement,nincluding membership for complex projects.Manage all establishment license renewals andndevice listing activities for North America.Evaluate proposed product modifications for regulatorynimpact on a world-wide basis. Coordinate international Regulatory Assessmentsnas needed.Craft regulatory procedures to ensure compliancenand continuous improvement within the regulatory function.Develop solutions to a variety of problems ofnmoderate scope and complexity.Participate in the development, review andnapproval of product labeling. QualificationsA Bacheloru2019s Degree and a minimum of 2 - 4 yearsnrelated work experience is required.Knowledge of Title 21 of the US Code of FederalnRegulations (21 CFR 800-1299) is required. Knowledge of US Federal Food, Drug, and CosmeticnAct (FD&C) Section 510(k) is required. Knowledge of European Medical Devices Directiven(93/42/EEC as amended by 2007/47/EC) is preferred. Knowledge of Risk Management Standard ISO 14971nis preferred. Knowledge of International Medical Devicenrequirements (China, Japan, Canada, Australia, Brazil, Russia, etc.) isnpreferred. Experience with establishment licensenmaintenance and device listing in the US is required.Experience with FDA systems (FURLS and CECATS)nis required. Experience with FDA WebTrader is preferred.Knowledge of Quality Management System StandardnISO 13485 and MDSAP is preferred. Excellent written and oral communication skillsnare required. Good analytical thinking, organization and problem-solvingnskills are required. Proficiency in Microsoft Office and all relatednapplications is required. This position will be located in Santa Ana, CAnand may require up to 10 % domestic travel. Johnson & Johnson Family of Companies arenequal opportunity employers, and all qualified applicants will receivenconsideration for employment without regard to race, color, religion, sex,nsexual orientation, gender identity, genetic information, national origin,nprotected veteran status, disability status, or any other characteristicnprotected by law.n

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