Integra LifeSciences

  • RA Specialist

    Vacancy ID
    2018-26294
    Location
    JP-Tokyo
    Position Type
    Regular Full-Time
    Category
    Regulatory Affairs
  • Overview

    Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.

     

    Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery.  In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.


    Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

    Responsibilities

    Product Registration

    -Support Japanese distributors and RA consultant company for their preparing Shonin Application / Partial Change Application / Class 1 Notification

    -Prepare Shonin Application / Partial Change Application / Class 1 Notification

    -Support Japanese distributors for their preparing QMS Application

    -Manage Shonin documents registered in Japan

    Interact with Japanese authorities and Medical Industry Groups

    Manage reimbursement

     

    Others

    -Support QMS Application for Japanese distributor

    -Support QA section for FMR

    Qualifications

    Education and Experience

    • Minimum level of education needed to perform duties
    • Minimum 5 year RA experience in Pharmaceutical / Medical Device (Class IV) Industries

     

    Essential Skills and Abilities

    • Excellent verbal and written communication skills
    • Ability to multiple tasks, prioritize and work under pressure
    • Strong negotiation skills with Japanese authorities (MHLW, PMDA, TMG, Notified body)
    • Good organization skills and ability

     

    Competencies

    • Business level English
    • Computer skills – MS-Word, Excel, PowerPoint

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed