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Senior Regulatory Affairs Specialist Job (Somerville, NJ, US)

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Johnson & Johnson companies are equal opportunity employers.

Senior Regulatory Affairs Specialist-9687141116

Description

Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Regulatory Affairs Specialist to be located in Somerville, New Jersey.

The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures, and energy based surgical devices. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of surgery. Ethicon Endo-Surgery, Inc. was started within Ethicon, and was separated and moved to Cincinnati, Ohio over 20 years ago, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today along with innovative energy devices for surgery.

Under little to no supervision, the Senior Regulatory Affairs Specialist provides assistance in preparation and submission of global regulatory documents. The position may act as Team Lead and is accountable for the success of projects. An individual in this position frequently has significant amounts of critical organizational knowledge. He/she serves as a consultant and technical expert on Regulatory Affairs matters.

The Senior Regulatory Affairs Specialist provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. The individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. The Senior RA Specialist defines data and information needed for regulatory approvals and develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations. He/she provides Regulatory Affairs support during internal and external audits. The individual plans schedules for regulatory deliverables on a project and monitors project through completion. The role assists in the development of best practices for Regulatory Affairs processes. The Senior RA Specialist represents Regulatory Affairs on cross-functional project teams. The role also partners with other functions to define and obtain data to assist with regulatory submissions.

Qualifications


A minimum of a Bachelor’s Degree with a minimum of 7 years of experience OR an advanced degree with 4 years of experience is required. 5+ years experience in Regulatory Affairs is preferred. Global regulatory affairs experience is required. Direct experience with global regulatory submissions is required, including interaction with regulatory bodies. Experience with Ethicon products or similar devices is preferred. Excellent oral and written communication skills required.

This position is located in Somerville, NJ and may require up to 10% travel.

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Somerville
Organization: Ethicon Inc. (6045)
Job Function: Regulatory Affairs

Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

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