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    Principal Regulatory Affairs Specialist- USA Remote - Marlborough, United States - AngioDynamics

    AngioDynamics
    AngioDynamics Marlborough, United States

    1 week ago

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    Description


    Performs full-range of regulatory functions required for Global product registrations, new product development, and internal documentation review for assigned strategic business units serving as the Regulatory Affairs resource.

    This role manages assigned regulatory programs working towards successful approval and/or clearance of new and/or revised products.
    Essential Duties and Responsibilities

    • Provides Regulatory Affairs guidance throughout the product development cycle, and coordinating team inputs for submissions.
    • Functions as Regional Regulatory Affairs Project Manager. Prepare reports including the priority list of projects, status and estimated completion dates as required.
    • Prepares and reviews submissions for global regulatory applications as well as internal regulatory file documentation.
    • Advise on requirements for FDA registration and CE mark and support preparation of the Technical File, when required.
    • Conducts review of device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.
    • Keeps AngioDynamics management informed of new and revised international regulatory requirements.
    • Maintain AngioDynamics' regulatory files.
    • Manage Regional internal audits, customer audits, and third-party audits, including those Regional regulatory agencies, and US as necessary, and serves as a Deputy Liaison for certain regulatory inspections when required.
    • May direct and coordinate activities of less senior Regulatory Affairs staff, including coaching, mentoring, advising and providing feedback.
    • Provides technical guidance to team during the course of submission preparation and interaction with regulatory bodies.
    • Reviews and edits submissions prepared by team members.
    • Supports and maintains Quality initiatives in accordance with the Quality Policy.
    • Provides Regulatory Affairs training/mentoring to other employees.
    • Implements regulatory strategies for new and modified products.
    • Reviews and assesses product and manufacturing changes for compliance with applicable regulations.
    • Conducts regulatory due diligence for potential partners/products.
    • Prepares Field Action reports to fulfill global regulatory requirements.
    • May perform other duties as assigned.
    Education and Experience

    • Bachelor's Level of Degree in the scientific or technical discipline field of study.
    • 10-12 years of demonstrated experience in Regulatory Affairs. Medical industry experience preferred.
    • No Certifications Required.
    • Any preferred education, experience or certifications: RAC Certification or equivalent preferred but not essential.
    Skills/Knowledge

    • Knowledge of 21 CFR/GMP/ISO 13485 series regulations and guidance.
    • Demonstrated experience in the successful preparation, submission and prosecution of regulatory submissions, including 510(k), IDE and Technical Files for US and international registrations. Experience supporting international clinical studies would be an advantage.
    • Demonstrated ability to manage Notified Body, FDA and other third-party audits.
    • Exceptional interpersonal skills.
    • Excellent written and oral communication skills.
    • Excellent organizational skills.
    • Working knowledge of Microsoft Office.
    • Knowledge of medical product development and design control.
    • Fluent in English (both written and verbal).
    • Ability to effectively communicate both internally and externally.
    • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence.
    PHYSICAL/WORK REQUIREMENTS

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    While performing the duties of this job:

    • Work safely and follow all OSHA regulations and company safety policies and procedures.
    • For all on-the-job injuries or accidents, must notify manager/supervisor immediately.
    • Exposure to: Standard office environment.
    * frequently
    * occasionally

    • Ability to regularly sit or stand for extended periods of time.
    • This position requires some travel up to 10% of the time

    EMPLOYEE ACKNOWLEDGMENT

    By signing the Learning & Development training form, I understand that the company reserves the right to add to or revise an employee's job duties at any time at its sole discretion.

    All requirements are subject to possible modification to reasonably accommodate individuals with disabilities. This document does not create a contract of employment between AngioDynamics and any individual, express or implied.

    #J-18808-Ljbffr
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