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Lead Analyst, R&D Technical Writing

at Comrise

Posted: 9/7/2019
Job Reference #: 31329

Job Description

  • Job Location(s)US-CO-Denver
    Posted Date2 months ago(7/11/2019 11:50 AM)
    Job ID
    Position Type
    Contract (Full-Time)
    # of Openings
  • Overview

    • Preferred 3 years’ experience performing Clinical Evaluations and writing/updating Clinical Evaluation Reports (CERs).
    • Knowledge of MEDDEV 2.7.1 Rev. 4 and the European Medical Device Regulation (EU MDR) as it pertains to CERs.
    • The candidate should have excellent written and verbal communication skills, possess a strong sense of responsibility and urgency.
    • Participates in core process steps for systematic literature reviews including search, screen, data extraction, analysis, and synthesis of the literature for CER processes.
    • This position requires the ability to interpret data from scientific literature and clinical studies and summarize the results and in a clear, concise, and scientifically accurate manner in the CER.
    • Strong knowledge and experience in Professional Medical Writing (Medical/Clinical; Regulatory; and Safety).
    • Preferably someone who has knowledge of the medical minimal invasive space or is a quick learner.


    • Experience in medical device industry: 5 years minimum
    • Clinical Affairs/Medical Writing: 3 years (Preferred)

    • Bachelor’s (Required)
    • Master's (Preferred)

    • San Jose, CA
    • Can work remote for 50-70% of the time.

    Work authorization:
    • United States (Required)

    • 6 months

    Contract Renewal:
    • Possible

    Full Time Opportunity:
    • Yes

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