Project Leader I, Regulatory Affairs-9829140530
Description
Vistakon, a Johnson & Johnson Company, is currently recruiting for a Project Leader I, Regulatory Affairs located in Jacksonville, FL.
Johnson & Johnson Vision Care, Inc., Vistakon® Division of Johnson & Johnson Vision Care, Inc., specializes in disposable contact lenses, which it markets under ACUVUE® Brand contact lenses. Ever since ACUVUE® 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 minimal supervision, will review and analyze the impact of modifications to manufacturing process, product and packaging to the registration status of approved products and determines the appropriate regulatory pathway. This individual prepares documents in support of 510(k), PMA/Supplements and Annual Reports submission to FDA. He/she reviews and updates EC Technical Files in support of CE Marking of product for the European Union. The individual adheres to environmental policy, procedures, and supports department environment objectives
The Project Leader I, Regulatory Affairs evaluates manufacturing changes, for regulatory impact and accurately describes these changes for ease of regulatory review. The individual prepares annual reports, supplement and amendments for submission to FDA, as well as internal regulatory documentations. He/She represents Regulatory Affairs on cross functional teams. The Project Leader I plans schedules for regulatory deliverables on a project and monitors project through completion. The individual assists in the development of best practices for Regulatory Affairs processes and performs other related duties as assigned by management.
Qualifications
A minimum of a Bachelors degree is required. A degree in a scientific discipline is required. A minimum 4 years of working experience is required. A minimum of 2 years experience in a regulated industry is required. Strong communication, organizational, negotiation and interpersonal skills required. General knowledge, understanding and application of principles, concepts and practices of FDA regulations required. Regulatory knowledge to maintain legal status of products and minimize risk preferred. Broad based technical knowledge and experience with diverse areas of business (e.g. R&D, Operations, QA, laboratories, marketing, etc.) preferred. Proficiency in MS Office is required. Candidates must be self-motivated and committed to a team approach. Must have the ability to organize and analyze technical data and identify issues or gaps. Must have the ability to provide innovative solutions within the boundaries of Regulation.
This position is location in Jacksonville, FL and may require up to 10% travel.
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Primary Location:North America-United States-Florida-Jacksonville
Organization: Johnson & Johnson Vision Care, Inc. (6094)
Job Function: Regulatory Affairs
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