Johnson & Johnson Careers
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Project Leader I, Regulatory Affairs
Requisition ID: 3487170817
Johnson & Johnson Vision Care is recruiting for a Project Leader I, Regulatory Affairs, located in Jacksonville, FL with a minimum of 10% 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 limited supervision, will be responsible for managing projects related to meeting regulatory requirements on a worldwide basis with focus on labeling for new and existing products.
• Provides strategic regulatory guidance to product teams to help determine the appropriate regulatory strategy and pathway for implementation of new packaging.
• May include preparation and submission of registration documents such as 510(k)s, PMAs, EU Technical Files (CE Mark) and other health authority communications.
• Provides strategic input to new product labeling development, as well as communication of the global regulatory perspective regarding new claims for marketed products in a cross-functional setting
• Identify the least burdensome approach to promote speed to market and compliance with applicable regulations. This individual may also be responsible for advertising promotion review/approval, and re-registration activities in support of OUS registrations, or other sub-functional areas within the department as needed.
• Organizes project teams, initiates project schedule documentation and provides project leadership on a worldwide basis in order to achieve desired outcomes within defined timeframes
• Facilitates mentoring for the Regulatory Affairs associates
• Provide Regulatory Affairs support during internal and external audits.
• Assists in the development of best practices for RA processes, partners with other functions to define and obtain data to assist with regulatory submission. These activities may involve discussion and coordination of activities with business partners.
• A minimum of a Bachelor’s Degree is required
• A minimum 4 years of working experience within the Over-the-Counter (OTC)/ prescription Pharmaceutical, or Medical Device Regulatory environment or 0-3 years with a PharmD or PhD is required
• General knowledge, understanding and application of principles, concepts and practices of FDA regulations is required
• Regulatory knowledge to maintain legal status of products and minimize risk requirement is required
• Knowledge of regulatory requirements (FDA & FTC) and general advertising standards associated with promotion of medical devices is preferred
• Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, laboratories, marketing, etc.) is required
• General working knowledge of MS Office products and Adobe Professional is required
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Johnson & Johnson Vision Care, Inc. (6094)