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Senior Regulatory Affairs Specialist

Company: CareFusion
Location: Warwick
Posted on: November 7, 2019

Job Description:

Job Description Summary Job Description This position will be working in the BD Interventional (BDI) Surgery Business Unit focusing on implantable devices. Under the guidance of the Senior Manager, Regulatory Affairs, the position will provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical device regulations in U.S. and global regions. Additionally, the position will provide regulatory support to marketed products and ensure company's regulatory compliance status. Responsibilities: - Coordinate, prepare, and execute US FDA 510(k) submissions to the US FDA and all other applicable global regulatory authorities, with a focus on Class II implantable devices. - Act as liaison with FDA and all global regulatory authorities, as applicable, in support of global submissions. - Facilitate creation and communication of responses to any requests for information from the FDA and/or other regulatory authorities, related to these submissions. - Assess necessity for reporting changes to FDA (and other regulatory authorities as applicable) for proposed device modifications. - Prepare robust justifications for changes that do not require supplements or notices. - Assist Product Development and Quality Assurance in planning testing that will ultimately be used in regulatory submissions. - Provide regulatory support on a range of activities which include domestic/international submissions, change assessments, quality system support, post market surveillance, and other compliance activities. - Collaborate effectively with project teams to identify risks and risk mitigation strategies. - Coordinate and prepare technical files for submissions to notified bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R & D, Quality, Manufacturing, etc.). - Assist in the review and approval product labeling, promotional, and advertising materials to ensureregulatorycompliance. - Assist in updates to standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards. - Coordinate and respond to requests for product information, and questionnaires requested by customers. - Remains current on regulations affecting BD products and keep the relevant team and supervisors informed about potential impact. Qualifications - B.S. in Life Sciences degree or BA with relevant (regulatory/medical device) experience - 3-5 years experience working in Regulatory Affairs within the medical devices industry required - Professional certifications preferred (RAC) - Knowledge and experience with regulatory requirements for medical devices (IDEs, PMAs ,510(k)s, CE mark technical files and design dossiers). - Good oral and written communications skills - analytical thinking and technical writing - Ability to effectively work on cross-functional teams - Ability to manage several parallel deliverables. - Ability and desire to travel as needed. Primary Work LocationUSA RI - Warwick Additional Locations Work ShiftUS BD 1st Shift 830am-5pm (United States of America)

Keywords: CareFusion, Warwick , Senior Regulatory Affairs Specialist, Other , Warwick, Rhode Island

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