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Regulatory Affairs Specialist
Requisition ID: 9280180417
Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Regulatory Affairs Specialist in Santa Ana, CA. JJSV designs, manufactures, and distributes medical devices for the surgical treatment of anterior segment ophthalmic disorders, most notably cataract removal.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
The Johnson & Johnson Surgical Vision goal is improving sight throughout a patient’s lifetime. J&J Surgical Vision is well positioned to address a full range of vision health needs for global markets: The No. 2 global provider of CATARACT products and a leader in presbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops. Johnson & Johnson Surgical Vision has operations in the United States, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Our associates around the world are committed to expanding our brands and fortifying our position as the worldwide leader in the industry.
The primary responsibility of this individual is to provide support to our international regulatory associates. You, Regulatory Affairs Specialist, will act as liaison between our regulatory teams and our R&D, quality, and manufacturing sites, ensuring that all supportive documentation is crafted and delivered in support of our foreign registrations.
The Specialist, under limited supervision, will also be responsible for capturing critical metrics and performance indices, and reporting this information to senior management. Other responsibilities include, but are not limited to:
- Provide regulatory support to project teams, creates detailed Regulatory Plans/strategies and in-depth team involvement, including membership for complex projects.
- Manage all establishment license renewals and device listing activities for North America.
- Evaluate proposed product modifications for regulatory impact on a world-wide basis.
- Coordinate international Regulatory Assessments as needed.
- Craft regulatory procedures to ensure compliance and continuous improvement within the regulatory function.
- Develop solutions to a variety of problems of moderate scope and complexity.
- Participate in the development, review and approval of product labeling.
- A Bachelor’s Degree and a minimum of 2 - 4 years related work experience is required.
- Knowledge of Title 21 of the US Code of Federal Regulations (21 CFR 800-1299) is required.
- Knowledge of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is required.
- Knowledge of European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) is preferred.
- Knowledge of Risk Management Standard ISO 14971 is preferred.
- Knowledge of International Medical Device requirements (China, Japan, Canada, Australia, Brazil, Russia, etc.) is preferred.
- Experience with establishment license maintenance and device listing in the US is required.
- Experience with FDA systems (FURLS and CECATS) is required.
- Experience with FDA WebTrader is preferred.
- Knowledge of Quality Management System Standard ISO 13485 and MDSAP is preferred.
- Excellent written and oral communication skills are required.
- Good analytical thinking, organization and problem-solving skills are required.
- Proficiency in Microsoft Office and all related applications is required.
- This position will be located in Santa Ana, CA and may require up to 10 % domestic travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-California-Santa Ana
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