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Conshohocken

    Senior Regulatory Affairs Associate Conshohocken, PA - The National Coalition of Healthcare Recruiters

    The National Coalition of Healthcare Recruiters
    The National Coalition of Healthcare Recruiters Conshohocken, United States

    2 days ago

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    Description
    (Only QUALIFIED Healthcare Professionals accepted)

    Hospital/Clinic - Quality Medical Manger (QMM) - Senior Regulatory Affairs Associate Conshohocken, PA

    The Senior Regulatory Affairs Associate is responsible for assessing and ensuring regulatory compliance of the quality management system.

    Development of regulatory documents; planning, tracking, execution, and archival of regulatory submissions; performing regulatory landscape; and regulatory affairs project management in support of designated activities.

    Ideally, the incoming candidate has excellent attention to detail and organizational skills, effective verbal and written communication skills, and the ability to work independently and in a team environment.

    Must have medical device or 21 CFR 820 or ISO 13485 experience.


    Duties & Responsibilities:

    Generate audit agenda, plan, summary report, and perform internal|external audits.


    Planning, managing, and tracking successful FDA submissions.


    Coordinate and support management of external audit scheduling.


    Support management of supplier qualification program.


    Initiate, review, and investigate quality events.


    Perform FDA|AATB reportability determination for quality events.


    Author|revise procedures according to FDA, AATB, and other regulations (as appropriate).


    Prepare regulatory documents for FDA|AATB for reportable events.


    Assist with regulatory submissions for TRG letters, Request for Designation (RFD), and Pre-RFD.


    Complete submission|update of FDA registrations.


    Complete state license application submissions and renewals.


    Support development of validation protocols to verify compliance with regulatory requirements.


    Review validation protocols to verify compliance with regulatory requirements.


    Support new projects and product development.


    Monitor regulatory updates.



    Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards.


    File and maintain records in accordance with standard operating procedures.


    Education & Experience:

    Bachelor's degree in biological science or related field required.



    Minimum 5 years of quality and|or regulatory experience in an FDA regulated environment for HCT|Ps and|or medical devices (or related field).


    Must have medical device or 21 CFR 820 or ISO 13485 experience

    Salary:

    $75k

    Benefits:

    401(k)


    Health insurance


    Dental insurance


    Vision insurance


    Paid time off

    Ready to join a fast growing, supportive team in an excellent working environment? We need an organized team player with a great attitude to do whatever needs to get done We offer competitive pay with great benefits and the chance to grow with us If you are interested, please contact us.

    We look forward to hearing from you. Please send your resume to

    Brian Torchin | CEO
    HCRC Staffing
    Office

    #J-18808-Ljbffr
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