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Regulatory Affairs Specialist II (Wound Closure & Healing) - Ethicon, Inc.

Company: Disability Solutions
Location: Raritan
Posted on: June 1, 2024

Job Description:

Ethicon, Inc., part of Johnson & Johnson MedTech, is currently recruiting for a Regulatory Affairs Specialist II to support our Wound Closure & Healing business. The preferred location for this role is within a commutable distance of Raritan, NJ however remote options within the United States will be considered on a case-by-case basis. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at The Regulatory Affairs Specialist II provides regulatory guidance to project teams in strategic planning and related submissions to support Ethicon Wound Closure & Healing (WCH) products. Under minimal supervision, the individual develops and executes regulatory strategy for significant change supplements and 510(k) registrations to support continued commercialization of products in key countries. The Specialist II helps to define data and information needed for regulatory actions in conjunction with cross-functional teams. He/she guides conformance with applicable regulations through the development of best practices for Regulatory Affairs processes, procedures and systems. DUTIES & RESPONSIBILITIES: --- Ensures compliance with regulatory agency regulations and interpretations. --- Prepares responses to regulatory agencies' questions and other correspondence. --- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. --- Provides solutions to a variety of problems of moderate scope and complexity. --- Researches and collects data; and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates. --- Advises on regulatory labeling requirements specifications for modified products, and reviews product labeling to ensure compliance. --- Provides regulatory guidance to project teams and responds to product information requests. --- Provide Regulatory Affairs support during internal and external audits. --- Assists in the development of best practices for Regulatory Affairs processes. --- Represents Regulatory Affairs on cross-functional project teams. --- Responsible for communicating business related issues or opportunities to next management level. --- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. --- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. --- Performs other duties assigned as needed. The base pay range for this position is $75,000 to $105,000 based on experience . The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

Keywords: Disability Solutions, New Brunswick , Regulatory Affairs Specialist II (Wound Closure & Healing) - Ethicon, Inc., Other , Raritan, New Jersey

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