Integra LifeSciences

  • Senior Regulatory Affairs Specialist

    Vacancy ID
    2018-26661
    Location
    IE-Tullamore
    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 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

    Responsibilities

    The Sr. RA Specialist is the regulatory liaison between the Tullamore manufacturing plant and the Codman Specialty Surgical and Corporate Regulatory Teams.

     

    To perform this job successfully, a individual must be able to perform each essential duty satisfactorily.

    • Represents regulatory affairs on project/product development teams.
    • Responsible for maintaining EU Design Dossiers, CE Certificates, and the Essential Requirements Checklist.
    • Supports domestic and international registration efforts including 510k, Certificate of Foreign Government, Canadian licensing, and other international registration requests.
    •  Reviews and approves product/facility change orders, label changes, and maintains the list of External Standards that apply to the Tullamore products.
    • Works with their manager to prioritize regulatory workload based on compliance and business objectives.
    • Works with their manager to make regulatory decisions that allow the company to achieve its goals while maintaining regulatory compliance.

    Qualifications

     

    • Bachelor’s degree (or equivalent international degree)
    • 3-5 years of experience or equivalent combination of education and experience in supporting medical device manufacturing.
    • Proven skills in the developing CE registrations and US PMA/510(k) Premarket Notifications - Required.
    • Possess knowledge of US FDA regulations, ISO Standards, and European Medical Device Directive (MDD) Required.
    •  Experience working with US FDA, European Notified Bodies and Competent Authorities and other regulatory agencies. The individual must have strong writing, data analysis, and communication skills - Required.
    •  Ability to handle multiple demanding projects - Required.

     

    [1] 510k not essential

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