WellDoc, Inc.

  • Senior Documentation Specialist

    Job Locations US-MD-Columbia
    ID
    2019-1083
    # of Openings
    1
  • Overview

     

    Company & Culture

     

    Welldoc is a digital health technology company that develops mobile solutions to drive behavioral and clinical change in chronic disease. Welldoc’s goal is to improve patient self-management and help physicians overcome gaps in the delivery system to improve clinical outcomes and decrease cost. Welldoc has commercialized BlueStar®, the first digital app with proven clinical and economic outcomes for adults with type 2 diabetes. This app is designed to fill the support gap between patients and providers during the 8700 hours that individuals live their lives outside the healthcare system each year. Welldoc has a proven track record of contributing published, peer-reviewed clinical evidence since 2008 and continues to be a thought-leader in our space. BlueStar® was recently recognized as the “Best Personal Health App” in the 2019 MedTech Breakthrough Awards Program, and was the winner of the Digital Diabetes Congress 2019 Mobile App Contest. For more information, visit www.welldoc.com  and www.bluestardiabetes.com.

     

    Job Purpose

     

    As a documentation specialist, you will work closely with different organization in the company to help documenting the quality systems requirements.

     

    Contribute and participate in the implementation of document and change control processes and systems for compliance to applicable medical device regulatory and quality management system (QMS) requirements.

    Responsibilities

    • Support the management of all documentation and records for QMS (e.g. policies, procedures, etc.), production (e.g. batch records) and Regulatory Affairs (e.g. 510(k) compilation and submission to FDA)
    • Reviewing for and ensuring good documentation practices (GDP) compliance with respect to QMS and production related records and documentation
    • Supporting or co-managing the document and change control process to include working directly with authors, reviewers, and approvers to facilitate document and change order workflow
    • Conducting required periodic review/inspection assessments of QMS documentation
    • Assist with non-conformity and corrective and preventive action (CAPA) processes per US 21CFR820
    • Maintain complaint records, and support regulatory reporting of device incidents

    Qualifications

     

    Required Education & Special Skills 

     

    • Minimum of a Bachelor’s Degree in science, engineering, information technology, or business.
    • 1-3 years of working experience in a Document Control or administrative Quality role in a regulated field.
    • Healthcare domain knowledge includes disease management a plus (note: health care not health insurance)
    • Excellent verbal and written communication skills
    • Demonstrated ability to work independently and in a team-based environment
    • Proficiency in Microsoft Office (Word, Excel, PowerPoint) and Acrobat
    • Experience utilizing and/or administering an electronic document management system is a plus
    • Working knowledge of 21CFR Parts 11 and 820, and ISO 13485 QMS is a plus
    • Experience auditing or reviewing Design Control and production records
    • Experience with JIRA, Confluence or related software is a plus

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