Johnson & Johnson Careers
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Project Leader I, Regulatory Affairs
Requisition ID: 6404170725
Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Project Leader I, Regulatory Affairs. This position is located in Jacksonville, FL with a minimum of 10% Domestic travel.
Johnson & Johnson Vision Care (“JJVC”) specializes in disposable contact lenses, which it markets under ACUVUE® Brand Contact Lenses. Ever since the ACUVUE® Brand transformed vision correction in 1988 with the world's first soft disposable contact lenses, we've passionately pursued new technologies and the highest quality standards. We're proud that ACUVUE® lenses are worn by more people than any other brand.
The Project Leader I, Regulatory Affairs, under some supervision, 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, the Project Leader I, Regulatory Affairs will:
• In interactions with cross functional partners, provides regulatory guidance to project teams to help determine the appropriate regulatory strategy and pathway for new product development and existing brand management initiatives.
• Develop regulatory project plans and monitor regulatory deliverables on a project through completion
• Prepare and submits registration documents such as 510(k)s, PMAs, EU Technical Files (CE Mark) and other health authority communications
• Research, collect data, and responds to requests to provide routine regulatory information to associates and affiliates.
• Prepare regulatory labeling requirements specifications for new and modified products; reviews 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
• Adheres to environmental policy and procedures and supports department environmental objectives.
• Impact assessment of modifications to manufacturing process, product, and packaging to the registration status of approved products and help determine the appropriate regulatory pathway
• Re-registration activities in support of OUS registrations
• A Bachelor’s degree, preferable in a scientific discipline with a minimum of 4 years Regulatory Affairs experience in a regulated industry is required.
• Strong project management skills; flexibility and initiative to work on multiple projects is required.
• Ability to organize and analyze technical data and identify issues or gaps is strongly preferred.
• Ability to provide innovative solutions within the boundaries of Regulation is required.
• Experience with US & Worldwide regulatory systems is required.
• Demonstrated knowledge of medical device regulatory requirements and processes is preferred.
• Self-motivated and committed to a team approach is required.
• Strong organizational, communication and interpersonal skills is required.
Johnson & Johnson Vision Care, Inc. (6094)