• Regulatory Affairs/Regulatory Reporting Specialist

    Posting Date 1 month ago(11/15/2018 10:03 AM)
    Requisition ID
    2018-3841
    Job Location(s)
    Vandergrift PA United States
    Travel
    Less than 10%
    Shift Type
    First
    Position Type
    Full Time
    Company
    Cook Vandergrift
    Category
    Regulatory Affairs
  • Overview

    The Regulatory Affairs / Regulatory Reporting Specialist at Cook Vandergrift is responsible for the planning and preparation of submissions to obtain regulatory approvals for new and modified Class I, II, III and IV medical devices in specific markets. Additionally, assesses complaints for regulatory reporting of Adverse Event (MDR, Vigilance, etc.), recalls, and associated correspondence to applicable regulatory bodies.

    Responsibilities

    • Serve as a liaison on regulatory issues between the Cook manufacturer and Cook Local Office and/or Cook Distributor
    • Prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific regions
    • Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability
    • Provide support to currently marketed products as necessary including input on change requests, etc.
    • Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations
    • Review and assess product complaints received from Cook global distribution centers
    • Assess complaints for adequate information to determine if event meets Regulatory reporting requirements
    • Generate appropriate regulatory reports based on assessment

    • Communicate with other Cook Companies globally as necessary for reporting
    • Generate responses to inquiries on AE reports from various global regulatory authorities
    • Assist in coordination of recall administration activities between manufacturer and distribution center

    Qualifications

    • Bachelor’s degree in a related field preferred; Associates degree in Regulatory Affairs; or experience of such kind and amount as to provide a comparable background

    • Proficient in reading, writing and speaking region specific language(s)

    • Computer experience required with working knowledge of Microsoft Office programs
    • General Cook product knowledge preferred
    • Medical device industry regulatory requirements knowledge preferred

     

    Physical Requirements:

    • Requires close visual acuity when working with computers, etc.
    • Requires occasional early morning or late evening teleconferences
    • International and domestic travel as required

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