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Quality Professional

Company: Careerbuilder-US
Location: Newark
Posted on: April 10, 2021

Job Description:

Title: Quality ProfessionalMandatory skills:MSOfficeIn Vitro Diagnostic Medical Device Regulation, IVDRclinical, clinical application, Medical DevicesISO 13485, ISO 2016, IVDR EU 2017, IVDR EU 746ABCC, NRCC, CACB, RCP, ABPclinical pathology, medical technologyR and DIVDR performance evaluation reports, LD policy, LD procedureDescription:Specific ResponsibilitiesPrimarily 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.Key Job AttributesWithin 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, 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.Job Requirements:Mandatory skills: MSOfficeIn Vitro Diagnostic Medical Device Regulation, IVDR clinical, clinical application, Medical DevicesISO 13485, ISO 2016, IVDR EU 2017, IVDR EU 746ABCC, NRCC, CACB, RCP, ABPclinical pathology, medical technologyR and DIVDR performance evaluation reports, LD policy, LD procedureVIVA USA is an equal opportunity employer and is committed to maintaining a professional working environment that is free from discrimination and unlawful harassment. The Management, contractors, and staff of VIVA USA shall respect others without regard to race, sex, religion, age, color, creed, national or ethnic origin, physical, mental or sensory disability, marital status, sexual orientation, or status as a Vietnam-era, recently separated veteran, Active war time or campaign badge veteran, Armed forces service medal veteran, or disabled veteran. Please contact us at hr@viva-it.com for any complaints, comments and suggestions.Please send your resumes to "staffing10@viva-it.com" and one of our recruiter will get in touch wiContact Details:Account co-ordinator: Muralikrishnan D, Phone No: (847) 786-5504, Email: staffing10@viva-it.comVIVA USA INC.3601 Algonquin Road, Suite 425Rolling Meadows, IL 60008hr@viva-it.com - http://www.viva-it.com

Keywords: Careerbuilder-US, Newark , Quality Professional, Other , Newark, Delaware

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