Regulatory Affairs Project Manager Job in Wayne, Pennsylvania Us
LifeScan, a member of Johnson Johnson's Family of Companies, is recruiting for a Regulatory Project Manager, located in Wayne, PA.
As the market leader and maker of blood glucose monitoring systems for home and hospital use, LifeScan, Inc., a Johnson Johnson Company, is dedicated to improving the quality of life for people with diabetes through our OneTouch Brand of blood glucose monitoring systems. The ONETOUCH Brand of consumer and institutional products includes portable electronic meters and disposable reagent test strips to provide accurate glucose readings, and also the software tools to transform this information into actionable health care decisions. To find out more about LifeScan, please visit our website at www.LifeScan.com .
The Regulatory Project Manager provides independent leadership, strategic planning and interpretation of regulatory requirements for new product concepts and emerging technologies for the LifeScan Franchise. Project Manager manages global regulatory submissions for US Class III (e.g., IDE, PMA,) and US Class II (e.g., 510(k)) devices. This individual will provide guidance, supervision and training to regulatory staff on project development support and implementation of complex submission strategies. Individual will also proactively interact with regulatory bodies to provide input on draft guidances and standards, to resolve issues and expedite approvals as needed.
Specific responsibilities will include the following; Provides independent regulatory leadership to development teams in coordinating and preparing global pre-marketing and related submissions to support optimal timelines for product launches. Provide 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 manufacture, 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. Work 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.
Qualifications
The minimum of a Bachelor's Degree is required. It is prefered that the degree is in engineering, scientific or professional discipline related to the practice of medicine and/or a license, registration, or certification permitting administration of health care. A minimum of 6 years of medical device, diagnostic or related industry experience is required. Must have the ability to work independently and as part of a project team. Regulatory Affairs submissions experience is required. Excellent analytical capability, communication skills, and independent problem-solving ability is required. Must have the ability to interface successfully with all levels of internal organization and regulatory authorities. Demonstrated expertise in obtaining approval for IDE, PMA and 510(k) submissions is preferred. Knowledge and understanding of US and international medical device regulations is required.
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