Regulatory Project Manager - Digital Solutions Job

Company Name:
J&J Family of Companies
Johnson & Johnson companies are equal opportunity employers.
Regulatory Project Manager - Digital Solutions-1889140326
Johnson & Johnson Diabetes Solutions is recruiting for a Regulatory Project Manager to be located in Wayne, PA.
Johnson & Johnson, through its operating companies, is the world''s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
Reporting to the Regulatory Director of Insulin Delivery & Digital Solutions, the Regulatory Project Manager provides independent leadership, strategic planning and interpretation of regulatory requirements for new product concepts and emerging technologies for the LifeScan and Animas businesses. Manages regulatory submissions for US Class III (e.g., IDE, PMA,) and US Class II (e.g., 510(k)) devices, EU Technical Files and supports global registrations. Provides guidance, supervision and training to regulatory staff on project development support and implementation of complex submission strategies. Proactively interacts with regulatory bodies to provide input on draft guidances and standards, to resolve issues and expedite approvals as needed. This individual provides independent regulatory leadership to development teams in coordinating and preparing global pre-marketing and related submissions to support optimal timelines for product launches. Provides guidance on the requirements for clinical studies and support the preparation of regulatory applications (e.g., IDE) for conducting clinical investigations. Guides conformance with applicable medical device regulations in product development and manufacturing, support of claims, and content of labeling and promotional materials. Defines data and information needed to obtain accelerated approvals. Plans and directs schedules for completion of regulatory deliverables on project and monitors project through completion. Works with internal and external partners in project development. Manages implementation of departmental projects to improve the overall effectiveness and efficiency of the department activities as a team leader and individual contributor. Establishes development and implementation schedules and monitors project through to completion. May mentor others in performing this function. Reviews and evaluates domestic and international regulatory impact of proposed product changes. Prepares submissions (or rationales justifying no submission) needed to approve implementation of such changes. Approves current product labeling changes and promotional material content through evaluating conformance with applicable regulations and commitments made in clearance, approval and related regulatory submissions for the product.
A Bachelor's degree is required; A minimum of 7 years of related experience in the medical device, diagnostic, or other regulated industry is required; A minimum of 5 years of Regulatory Affairs submissions experience is required; Demonstrated experience obtaining approvals is strongly preferred; Medical Device industry experience is preferred; Knowledge and understanding of US and European regulations is required; Experience managing 510k and PMA submissions is preferred; Creation of EU technical files is preferred; Ability to work independently and as part of a project team is required; Computer literacy is required; Excellent analytical capability, communication skills, and independent problem-solving ability is required; Ability to interface successfully with all levels of internal organization and external partners is required; Experience interfacing with regulatory authorities is strongly preferred; This position is located in Wayne, PA; Up to approximately 10% domestic travel is required.
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Primary Location: North America-United States-Pennsylvania-Wayne
Organization: Lifescan Inc. (6097)
Job Function: Submissions
Relocation: Eligible No
Travel: Yes, 10 % of the Time
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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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Req ID: 1889140326
Date: Thu, 03 04 2014 00:00:00 GMT
Country: US
State: PA
City: Wayne
Postal Code: 19080
Locale: en_US

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