Johnson & Johnson Careers
Regulatory Affairs Specialist II
Requisition ID: 5553190523
Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Senior Regulatory Affairs Specialist in 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 Senior Regulatory Affairs Specialist will provide regulatory support in any number of areas: review/analyze impact of modifications to manufacturing process, product, and packaging to the registration status of approved products and help determine the appropriate regulatory pathway, review/approve advertising & promotional materials, re-registration activities in support of OUS registrations, help develop regulatory strategies for new product development initiatives, and/or regulatory operations activities in archiving/assembling/publishing regulatory filings and other health authority communications.
- Coordinate and submit licenses and authorizations for the maintenance of existing products, international registrations and dossiers, updates to DOC (technical files), engineering and device change requests.
- Research, collect data, and respond to requests from regulatory agencies to prepare and submit documentation for marketing approvals (US, Canada and EU), as well as to provide routine regulatory information to associates and affiliates.
- Provide regulatory guidance to product development teams and responds to product information requests.
- Represent regulatory affairs in cross-functional project teams and plans schedules for regulatory deliverables on a project and monitors project through completion.
- Prepare regulatory labeling requirements specifications for new and modified products; review product labeling for existing products to ensure compliance.
- Assist in the development of best practices for Regulatory Affairs processes
- Provide Regulatory Affairs support during internal and external audits
- Adhere to environmental policy and procedures and support department environmental objectives.
• A minimum of a Bachelor’s Degree or equivalent with 2 years of working experience within a regulated environment OR a Master’s Degree/advanced degree with less than 2 years of working experience working in a regulated environment is required.
• Experience or training in the preparation of submissions of regulatory filings in the US or EU, or Canada is required.
• Experience with Class III medical devices within the US is preferred.
• Strong communication, organizational, negotiation and interpersonal skills is preferred
• Expert knowledge, understanding and application of principles concepts and practices of government regulations and standards is preferred
• Ability to organize and analyze technical data and identify issues or gaps is preferred
• Demonstrated skills in area of staff support and development (directly or indirectly) is preferred
• Foundational regulatory knowledge to maintain legal status of products and minimize risk is preferred.
• Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, Marketing, Clinical research etc.) are a plus.
• This position will be located in Santa Ana, CA and may require up to 20% domestic and/or international travel.
United States-California-Santa Ana-
AMO US Holdings, Inc.. (6234)