WellDoc, Inc.

  • Director/VP, Regulatory and Quality Systems

    Job Locations US-MD-Columbia
    ID
    2019-1070
    # 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

     

    • Provides leadership and oversees regulatory and quality activities for the development, delivery, and support of Welldoc’s digital therapeutic solutions
    • Ensures development and execution of global regulatory strategies and submission plans
    • Evaluates regulatory landscapes both nationally and internationally to provide strategic guidance to business strategy development
    • Ensures compliance with regulatory requirements for licensed products and products under development
    • Leads and drives Quality Management System (QMS) function and associated activities
    • Proactively provides guidance to the functional teams to ensure Regulatory and Quality System compliance
    • Represents Welldoc with regulatory authorities to support innovation and new programs

    Responsibilities

    Responsibilities

    • Develops regulatory strategies for Enforcement Discretion, Class I, Class II and Class III product registration in worldwide jurisdictions.
    • Represents Welldoc at regulatory and compliance meetings as our SME in compliance matters.
    • Direct submission of information to federal bodies, including the FDA and other regulatory authorities in Canada, Europe, Asia, Australia, Latin America and Africa.
    • Prepare, submit, and disseminate periodic reports internally and to regulatory bodies.
    • Coordinate with strategic partners where projects require joint regulatory cooperation
    • Review, analyze, and bring up to compliance all behaviors and paperwork regarding new and existing products and projects for any and all regulatory government agencies and/ or oversight.
    • Provide strategic and technical oversight to promote the compliance and quality of all products manufactured.
    • Ensure that Welldoc maintains the highest level of product quality, regulatory compliance, and clinical responsibility thereby ensuring patient safety.
    • Provide guidance relative to managing regulatory inspections and responding to any inquiries / observations appropriately.
    • Identify key regulatory issues for senior management and develop / deploy remediation.
    • Support the management of all QMS (e.g. policies, procedures, etc.), production (e.g. batch records) and Regulatory Affairs (e.g. 510(k) compilation and submission to FDA) related documentation and records
    • Oversee non-conformity and corrective and preventive action (CAPA) processes per ISO13485
    • Conduct internal audit function, including opening and overseeing resolution of CAPA incidents and providing guidance to staff accordingly
    • Develop and implement a system to drive a Culture of Quality

    Requirements

    • Bachelor’s and Advanced degree in related field (Chemistry, Biology, Engineering) or equivalent work experience, preferred
    • 10-15 years of experience in the medical device industry at a senior level.
    • Minimum of 10 years of senior experience in regulatory affairs
    • Thorough knowledge of global regulatory requirements, good manufacturing practices and quality system requirements
    • Extensive experience dealing with FDA, Notified Bodies and other regulators
    • Excellent interpersonal, organizational and communication skills
    • Demonstrated leadership and the ability to motivate others
    • Proficiency with MS Word, PowerPoint and Excel (statistics, graphing, presentations, etc.)
    • Willingness to continually develop and maintain technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices in submissions and regulatory requirements of medical devices

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