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REMOTE Medical Affairs IVDR Specialist

Company: GForce Life Sciences
Location: Orlando
Posted on: January 16, 2022

Job Description:

SummaryGForce Life Sciences' mission is to make an impact one person at a time. We do this by assisting our clients, consultants, colleagues, charities, and the clinical space. As one of America's Fastest Growing Private Companies (#8 in 2018 and #90 in 2019; identified by the Inc. 5000 rankings) as well as a repeat Best Company to Work For (Staffing Industry Analysts), our primary focus is matching highly targeted consultants to executives' needs in the medical device, pharmaceutical and biotech industries. Headquartered in Chicago with a presence in Boston, San Francisco, Florida and twenty other states, GForce has successfully been engaged in hundreds of engagements in many countries for clients ranging from Fortune 500 to startups.We consider our consultant employees to be the most important piece of the puzzle in this extremely competitive environment. Combine that with our deep client relationships, and attention to detail, and we feel strongly that this provides us with a strong advantage in the life sciences consulting industry.
Duties / Expectations of Role

  • Responsible for contributing to the implementation and execution of post-market In Vitro Diagnostic Regulations activities through medical assessments of LD products.
  • Serve as 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 products and new product development.
  • Work independently or as part of a larger team in the execution of assigned projects.
  • Perform literature-based searches to identify potential product risks across all LD product lines, including hardware, software and assays.
  • Actively collaborate with cross-functional key stakeholders (Commercial Product Quality, Risk Management, Clinical Affairs, etc.) in support of post market surveillance plan and report creation to assess the safety, effectiveness and performance of our regulated products/devices.
  • Maintain accurate documentation and files related to risk-benefit analyses and/or post-market surveillance activities.
  • Interacts directly with regulatory, clinical, marketing, manufacturing, 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 assessments of overall scientific and clinical/medical validity.
  • Perform special assignments and provide technical and clinical advice in area of expertise.
  • Preempts potential problems via post-market surveillance and provides effective input to potential safety impact of identified risks.
    Mandatory Requirements
    • M.D., Ph.D. or M.D./PhD. 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.
    • Typically 3 to 5 years of successful experience in related laboratory medicine or medical device field.
    • Experience in post-market surveillance.
      Nice to Have Requirements
      • Experience with ISO13485/2016 and/or IVDR EU 2017/746 is highly desirable.
        Term & Start
        • 12+ month contract
        • Remote - EST
          • 401(k) matching
          • Employer contributed competitive health benefits (medical, dental, vision)
          • Philanthropy driven culture
          • Consultant engagement social activities

Keywords: GForce Life Sciences, Orlando , REMOTE Medical Affairs IVDR Specialist, Healthcare , Orlando, Florida

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