Quality Professional 4/ Medical Affairs IVDR Specialist

Company: Rose International
Location: Newark
Posted on: May 2, 2021

Job Description:

** and those authorized to work in the U.S. can be considered as W2 candidates.** Job Title: Quality Professional 4/Medical Affairs IVDR SpecialistLocation: Newark, DE, 19702Duration:12 MonthsSchedule: 8AM-5PMDescription:---Business Unit / Segments.---Laboratory Diagnostics (LD).---(Products: Chemistry, Immunochemistry, Automation, Informatics, Hematology, Hemostasis and Specialty Products).Specific Responsibilities:---Primarily responsible for contributing to the implementation and execution of In Vitro Diagnostic Medical Device Regulation (IVDR) activities through medical assessments of 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 related field.---Experience with ISO13485/2016 and/or IVDR EU 2017/746 is highly desirable.---Currently fully remote, but desire option for future part or full time in person at Glasgow, DE site.---Travel requirement does not apply currently.

Benefits: - provided by Dice

Keywords: Rose International, Newark , Quality Professional 4/ Medical Affairs IVDR Specialist, Healthcare , Newark, Delaware