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Quality Professional 4

Company: rose international
Location: Newark
Posted on: July 12, 2019

Job Description:

Position Number: 318526

Location: Newark, DE

Desired Skill Set:
Technical, Regulatory Coordinator, Regulatory Affairs, Quality Control, Medical device, Marketing, Laboratory, Clinical

Position Description:



  • *C2C is not available**
  • *Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.**


    Job Title: Quality Professional 4

    Location: Newark, DE 19702

    Duration: 12+ Months

    Schedule: Shift 1; M-F (8:00 AM - 5:00 PM)

    Specific Responsibilities:



    • Primarily responsible for contributing to the implementation and execution of In Vitro Diagnostic Medical Device Regulation (IVDR) activities through medical assessments of Client Laboratory Diagnostics (LD) products.
    • Serve as a medical consultant to project teams for preparation of IVDR performance evaluation reports.
    • Advise on medical risks and benefits to evaluate product safety and effectiveness in laboratory medicine in support of functional group activities for commercialized/marketed products as well as for product development activities.
    • Contribute to post-market surveillance activities in alignment with LD policies and procedures and applicable standards/regulations.
    • Reports directly to Client LD Medical Affairs


      Key Job Attributes:



      • Within specific job description:



      • Works independently or as part of a larger team in the execution of assigned projects.
      • Maintains accurate documentation and files related to medical risk-benefit analyses and/or post-market surveillance activities.
      • Interacts directly with regulatory, clinical, marketing, and R&D as needed during the course of risk-benefit analyses and/or post-market surveillance activities and builds productive cross-functional working relationships.
      • Critically reviews analytical and clinical performance data and reports and provides assessment of overall scientific and clinical/medical validity.


        Critical Problem Thinking:



        • Demonstrates understanding of functionality/intended use of complex in vitro diagnostic laboratory medical devices and the application of medical laboratory results (e.g. biomarkers) in clinical practice.
        • Displays an expert level of critical thinking in applying principles of clinical laboratory medicine, including analytical laboratory practice (eg assay validation, quality control), regulations and clinical applications.
        • Proactive attitude with logical, data driven approach to problem solving.
        • Performs special assignments and provides technical and clinical advice in area of expertise.


          Education:



          • M.D., Ph.D. or M.D./Ph.D. in related areas with practical experience in clinical pathology preferred.
          • Equivalent combination of relevant education and experience, such as Masters in medical technology, laboratory science, chemical, physical, or biological science AND a minimum of 3 years of medical laboratory experience in clinical consultancy and technical and regulatory oversight, as outlined above, may be substituted as appropriate.
          • Board certification and ongoing accreditation by nationally and internationally known professional clinical and academic bodies such as ABCC, NRCC, CACB, RCP, and ABP preferred.


            Experience:



            • Typically 3 to 5 years of successful experience in a clinical laboratory diagnostics position.
            • Experience with ISO13485/2016 and/or IVDR EU 2017/746 is highly desirable.



Keywords: rose international, Newark , Quality Professional 4, Other , Newark, Delaware

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