Senior Regulatory Affairs Program Lead (Specialist IV)
- Santa Ana, CA
Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Senior Regulatory Affairs Program Lead (Specialist IV) in Santa Ana, CA or remote for the right candidate. 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 Program Lead (Specialist IV) 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.
In this role, you will:
- This position is within the Cataract Implants Product Portfolio team which includes support for Intraocular Lenses (IOL), Ophthalmic Viscosurgical Devices (OVDs), and other accessory devices.
- Support the transition and maintenance of technical documents according to the EU Medical Device Regulations.
- 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 Bachelor's degree with at least 6 years of related regulatory affairs experience in a health regulated industry experience OR An Advanced degree with at least 4 years of related regulatory affairs experience in a health regulated industry experience is required
- Demonstrable knowledgeable of FDA, EEA and other international regulations pertaining to the design, manufacture and commercialization of medical device is required
- Previous experience with class III medical devices is preferred
- Previous experience interacting directly with FDA is required
- Previous experience interacting with international Health Authorities is preferred
- Previous experience updating technical files and design dossiers is required
- Previous experience creating and submitting change notifications to regulatory agencies is required
- Previous project management/ project lead experience is preferred
- Previous experience conducting Copy Review of Advertising & Promotional Materials is preferred
- Strong communication, organizational, negotiation and interpersonal skills is preferred
- Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, Marketing, Clinical research etc.) and ability to effectively negotiate and influence cross-functional stakeholders, affiliates, and Regulatory agencies are a plus.
- The position will be based in Santa Ana, CA or remote for the right candidate with up to 10% travel is required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-California-Santa Ana-
Johnson & Johnson Surgical Vision, Inc (6234)
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