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Home Instead Senior Care

197 - 20852, Rockville, MD 20852
2.6 miles
Part-time

    Director, Regulatory Affairs & Quality Assurance

    DxNow
    Gaithersburg, MD 20877
    Full-time, Part-time
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    Job Description

    Director, Regulatory Affairs & Quality Assurance

    • Director, Regulatory Affairs & Quality Assurance

    Title: Director, Regulatory Affairs & Quality Assurance

    Location: Gaithersburg, MD

    Job Description:

    The Director, Regulatory Affairs & Quality Assurance is a core member of the DxNow, Inc., team, directly responsible for the development and implementation of the Company's Quality Management System as well as CE, ISO and FDA filings. This is a hands-on position requiring intimate involvement with all aspects of medical device regulatory and quality policy, procedure and implementation.

    Responsibilities:

    • Develop and implement a Quality Management System for DxNow's medical devices.
    • Prepare and submit regulatory applications such as FDA 510(k), CE and ISO.
    • Demonstrate an intimate knowledge of U.S. and international UDI labeling requirements and coordinate the implementation of such requirements.
    • Review device labeling and promotional material to ensure compliance with U.S. and international regulations.
    • Act as a core member of the Company's development and manufacturing teams, providing regulatory affairs feedback and guidance.
    • Perform internal and external audits to assure compliance with Company policy as well as agency requirements and regulations.
    • Review product and/or manufacturing changes for compliance with DxNow and external applicable policies and/or regulations.
    • Establish, track and manage regulatory project timelines.
    • Maintain well-organized, auditable regulatory files.
    • Manage quality-related activities with outside vendors.
    • Provide quality training to staff.
    • Other duties as required.

    Qualifications:

    • 5-10 years' hands-on life sciences regulatory experience. Ideally, experienced in 510(k) medical devices.
    • In-depth knowledge of quality management systems.
    • Past successful submissions of CE, ISO and FDA 510(k).
    • Minimum of Bachelor's degree in life sciences or engineering. Advanced degree preferred.

    Success Profile:

    • Ability to leverage the learnings and wisdom from regulatory/quality experience to help advise and support effective management decision-making.
    • Hands-on, action-oriented.
    • High-energy, motivated to achieve and succeed.
    • Self-starter able to work autonomously and within a cost-constrained environment.
    Posting ID: 567174738Posted: 2020-08-09