Johnson & Johnson Santa Ana , CA 92701
Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Senior Specialist Regulatory Affairs to be located in Milpitas, CA or Santa Ana, CA. JJSV designs, manufactures, and distributes products 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 regulatory support to New Product Development and Value Stream teams. The Specialist, under limited supervision, will be responsible for assessing device/manufacturing changes, developing regulatory strategies and preparing submissions including PMAs, PMA Supplements/Amendments/Annual Reports, 510(k)s, IDEs, Change Notifications and Technical Files (CE Mark).
You, Senior Specialist Regulatory Affairs, will act as regulatory liaison to U.S. Food & Drug Administration for Annual Reports and other regulatory submissions. The position requires extensive collaboration with colleagues in other functions to ensure team objectives and milestones are met in a timely manner.
You, the Senior Specialist Regulatory Affairs will:
Coordinate, compile, and submit Regulatory documents to FDA and other Regulatory Agencies, including EPA and International Authorities. Also includes the preparation of international documents, including Technical Files.
Work with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products.
Provide Regulatory support to project teams, creates detailed Regulatory Plans/strategies and in-depth team involvement, including Core Team membership for complex projects for New Product Development (NPD), and product Life-Cycle Management (LCM).
Evaluate proposed product modifications for Regulatory impact on a world-wide basis. Completes Regulatory Assessments as needed.
Ensure compliance with FDA and other applicable regulations and interpretations.
Prepare responses to FDA questions and other Regulatory correspondence.
Work under minimal supervision, with benefit of previous regulatory experience.
Requires a general use and application of Regulatory concepts, practices and techniques.
Develop solutions to a variety of problems of moderate scope and complexity.
Participate in the development, review and approval of product labeling.
Perform other duties as assigned by the manager of this position.
A Bachelor's Degree and a minimum of 4 years related work experience; Minimum of 2 years of experience with MS, or equivalent knowledge is required.
Knowledge of Title 21 of the US Code of Federal Regulations (21 CFR 800-1299) is required.
Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is required.
Experience with European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) is required.
Experience with of Quality Management System Standard ISO 13485 is required.
Experience with Risk Management Standard ISO 14971 is required.
Knowledge of International Medical Device requirements (China, Japan, Canada, Australia, Brazil, Russia, etc.) is preferred.
Excellent written and oral communication skills are required.
Good analytical thinking, problem solving and investigative skills are required.
Proficiency in Microsoft Office and all related applications is required.
This position will be located Milpitas, CA and may require up to 10% domestic and/or international travel or Santa Ana, CA and may require up to 50% domestic and/or international 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-
AMO Development, LLC (6242)