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Hudson

    Regulatory Affairs Specialist - Hudson, United States - Atrium Medical

    Atrium Medical
    Atrium Medical Hudson, United States

    3 weeks ago

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    Description

    Position Specific Requirements:

    • Responsible for internal, domestic, and international compliance activities working under the direction of the Regulatory Affairs Director.
    • Assists the Regulatory Affairs Director with regulatory strategy/plans and requirements.
    • Prepares worldwide regulatory submissions/registrations.
    • Participates in the review and disposition of labeling, promotional materials and product modification.
    • Prepares documentation and coordinates activities related to PMA's, 510k's, and IDE's.
    • Supports engineering changes through RA/QA practices by documentating the changes in compliance with Quality Systems Regulations (QSR), the Medical Device Directives, CMDR, and other International regulations.
    • Participates in cross functional departmental team projects and product development activities/meetings.
    • Provides support to RA Director for communication between Regulatory Agencies such as the Food and Drug Administration (FDA) and the European Notified Body.
    • Responsible for FDA/ISO/MDD/CMDR compliance documentation.
    • Assists in special projects as needed.
    • Contributes to team effort by accomplishing related duties as requested.
    Qualifications:

    Bachelor's Degree in Scientific/Engineering discipline. A minimum of three years experience in a regulatory environment. Willingness to handle a number of projects simultaneously in a fast paced environment. Ability to assist in regulatory planning and strategies for domestic (510(k)/IDE/PMA) and international submissions/registrations. Ability to represent Regulatory Affairs to other departments.

    For immediate consideration - please email your resume along to along with salary expectations

    Atrium Medical Corporation offers competitive salaries, exceptional benefits, and a business casual dress code. We do not accept unsolicited Agency Resumes. Atrium Medical Corporation is an equal opportunity employer dedicated to workforce diversity and a drug and smoke-free environment. Drug screening is required.
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