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    Clinical Evaluation Lead - Duluth, United States - Saviance Technologies

    Saviance Technologies
    Saviance Technologies Duluth, United States

    2 weeks ago

    Default job background
    Description
    The contractor will be responsible/accountable for the following,

    Act as the primary point of contact for the Clinical project lead and provide support in Life Cycle Management/Post Production risk review activities

    Activities include but not limited to, understanding and evaluating available clinical data on surgical products, reviewing data against MDR and MDCG Guidance documents and conducting gap assessments and remediation activities

    Provide clinical functional review and expertise on the assigned projects/tasks

    Be responsible for timely authoring (as applicable), revisions, update, on clinical related documents for Medical Device Regulation (MDR) remediation and Post production Risk Reviews (PPRRs), and post-market clinical plans

    Develop template for post-market clinical plan activities, including physician surveys, retrospective/prospective studies etc.

    Review large documents such as literature reports, clinical research protocols, and review template documents as assigned by the project lead/line manager

    Assist in literature review activities as assigned by the project lead and/or CDMA Franchise Head

    Attend Clinical team meetings, Clinical Sub team and Trial Team Meeting and any other project meetings as assigned by the Project Lead/Line Manager and represent the function

    Complete training activities to better understand product therapeutic area as assigned by the manager


    Qualifications:
    Bachelor's or Masters in Health related fields

    Excellent understanding of clinical trial regulations, GCP, MDR, MDCG etc.

    Strong experience in clinical evaluations of medical devices (ophthalmology preferred) for life cycle management, and remediation for MDR

    Good knowledge of the European medical device regulations (MDR), MDCG and PMCF requirements for medical devices

    Prior experience in planning/conducting/reporting physician surveys, registries etc is a bonus

    Experience in eye care/ophthalmology is preferred

    Strong communication and writing skills Strong project management and meeting facilitation skills
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